Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
Study NCT ID:
NCT03929250
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2019-04-21
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Centella Asiatica in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'soumyana@ohsu.edu', 'phone': '503-494-6878', 'title': 'Dr. Amala Soumyanath', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '0, 6, 12 and 24 hours after administration of each dose level (2g CAW or 4g CAW)', 'description': 'A standard multi-system questionnaire will record the type and severity (range 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal) of any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Excessive sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disappointment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Boredom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness/fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain or stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fainting/dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema or swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gas/indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal or metallic taste in mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain/cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Belching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine color change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness/dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin color change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash/hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin puffiness/ tissue fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ecchymosis, indurate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Human Plasma Concentration of Bioactives From Centella Asiatica.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'title': 'Asiatic acid', 'categories': [{'measurements': [{'value': '174', 'spread': '22', 'groupId': 'OG000'}, {'value': '372', 'spread': '53', 'groupId': 'OG001'}]}]}, {'title': 'Caffeic acid', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Dihydrocaffeic acid', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Dihydroferulic acid', 'categories': [{'measurements': [{'value': '9.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Dicaffeoylquinic acids', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Ferulic acid', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '3-(3-hydroxyphenyl)propionic acid', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Isoferulic acid', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Madecassic acid', 'categories': [{'measurements': [{'value': '107', 'spread': '18', 'groupId': 'OG000'}, {'value': '197', 'spread': '43', 'groupId': 'OG001'}]}]}, {'title': 'Monocaffeoylquinic acids', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Plasma Concentration Over Time (Area Under the Curve) From Centella Asiatica Water Extract Product.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'title': 'Asiatic acid', 'categories': [{'measurements': [{'value': '48755', 'spread': '7152', 'groupId': 'OG000'}, {'value': '91330', 'spread': '17723', 'groupId': 'OG001'}]}]}, {'title': 'Caffeic acid', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Dihydrocaffeic acid', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Dihydroferulic acid', 'categories': [{'measurements': [{'value': '35.6', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Dicaffeoylquinic acids', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Ferulic acid', 'categories': [{'measurements': [{'value': '11.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': '3-(3-hydroxyphenyl)propionic acid', 'categories': [{'measurements': [{'value': '56.8', 'spread': '31.7', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Isoferulic acid', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Madecassic acid', 'categories': [{'measurements': [{'value': '26771', 'spread': '3585', 'groupId': 'OG000'}, {'value': '48373', 'spread': '12476', 'groupId': 'OG001'}]}]}, {'title': 'Monocaffeoylquinic acids', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).', 'unitOfMeasure': 'ng/mL*hr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'title': 'Asiatic acid', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Caffeic acid', 'categories': [{'measurements': [{'value': '8.4', 'spread': '3', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Dihydrocaffeic acid', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Dihydroferulic acid', 'categories': [{'measurements': [{'value': '7.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Dicaffeoylquinic acids', 'categories': [{'measurements': [{'value': '2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Ferulic acid', 'categories': [{'measurements': [{'value': '14.1', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '3-(3-hydroxyphenyl)propionic acid', 'categories': [{'measurements': [{'value': '5', 'spread': '2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Isoferulic acid', 'categories': [{'measurements': [{'value': '7', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Madecassic acid', 'categories': [{'measurements': [{'value': '9.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Monocaffeoylquinic acids', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'The half-life (t1/2) of the known bioactive compounds was calculated from the plasma concentrations measured by high performance liquid chromatography tandem mass spectrometry to help determine dosage intervals.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'title': 'Asiatic acid', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Caffeic acid', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Dihydrocaffeic acid', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Dihydroferulic acid', 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Dicaffeoylquinic acids', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Ferulic acid', 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '3-(3-hydroxyphenyl)propionic acid', 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Isoferulic acid', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1', 'groupId': 'OG000'}, {'value': '1', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Madecassic acid', 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Monocaffeoylquinic acids', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'The time of maximum concentration (tmax) of the known bioactive compounds and their metabolites will be calculated from the concentrations measured by high performance liquid chromatography tandem mass spectrometry in order to help determine dosage intervals', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urinary Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'title': 'Asiatic acid', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Asiaticoside', 'categories': [{'measurements': [{'value': '20.7', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Caffeic acid', 'categories': [{'measurements': [{'value': '42.8', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Dihydrocaffeic acid', 'categories': [{'measurements': [{'value': '26.8', 'spread': '10', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Dihydroferulic acid', 'categories': [{'measurements': [{'value': '225.5', 'spread': '83.5', 'groupId': 'OG000'}, {'value': '225.1', 'spread': '94.8', 'groupId': 'OG001'}]}]}, {'title': 'Dicaffeoylquinic acids', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ferulic acid', 'categories': [{'measurements': [{'value': '146.8', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '137.4', 'spread': '24.6', 'groupId': 'OG001'}]}]}, {'title': '3-(3-hydroxyphenyl)propionic acid', 'categories': [{'measurements': [{'value': '223.4', 'spread': '76.7', 'groupId': 'OG000'}, {'value': '247.9', 'spread': '73.6', 'groupId': 'OG001'}]}]}, {'title': 'Isoferulic acid', 'categories': [{'measurements': [{'value': '65.9', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '225.1', 'spread': '15.9', 'groupId': 'OG001'}]}]}, {'title': 'Madecassic acid', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Madecassoside', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocaffeoylquinic acids', 'categories': [{'measurements': [{'value': '21.3', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over 12 hours post-administration', 'description': 'The concentration of bioactive compounds from Centella asiatica (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in a pooled urine sample collected over 12 hours after CAP administration and analyzed using high performance liquid chromatography tandem mass spectrometry.', 'unitOfMeasure': 'micrograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oral Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '98.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '720 minutes after administration', 'description': 'Oral temperature will be measured in degrees Fahrenheit by means of a thermometer.', 'unitOfMeasure': 'degrees Fahrenheit', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '4', 'groupId': 'OG000'}, {'value': '64', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '720 minutes after administration', 'description': 'Pulse rate will be measured peripherally over one minute.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Seated Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '4', 'groupId': 'OG000'}, {'value': '119', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '720 minutes after administration', 'description': 'Seated blood pressure will be measured in millimeters mercury.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '28', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '720 minutes after administration', 'description': 'Height in centimeters and weight in kilograms will be measured and aggregated to measure body mass index in kilograms per meter squared (kg/m2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants With Change in Electrocardiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0, 360 and 720 minutes after administration', 'description': 'Resting electrocardiography will be measured for up to five minutes using a five lead mobile electrocardiogram. The investigators will determine the number of participants who develop changes in electrocardiography compared to the zero minute timepoint following CAP administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Seated Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2g CAW Dose', 'description': '2g of Centella asiatica water extract in a standardized product.\n\n2g Centella asiatica water extract product: 2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}, {'id': 'OG001', 'title': '4g CAW Dose', 'description': '4g of Centella asiatica water extract in a standardized product.\n\n4g Centella asiatica water extract product: 4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'spread': '3', 'groupId': 'OG000'}, {'value': '69', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '720 minutes after administration', 'description': 'Seated blood pressure will be measured in millimeters mercury.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2g CAW Dose, Then 4g CAW Dose', 'description': 'Participants first receive a single dose of product containing 2g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of product containing 4g CAW.'}, {'id': 'FG001', 'title': '4g CAW Dose, Then 2g CAW Dose', 'description': 'Participants first receive a single dose of product containing 4g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of product containing 2g CAW.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Blood draws could not be successfully obtained', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants including those in the (a) 2g CAW, then 4g CAW arm or (b) 4g CAW then 2g CAW arm'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '5.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body temperature', 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees Fahrenheit', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'White blood cell', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^3 cells/cu mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Red blood cell', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^6 cells/cu mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Platelet', 'classes': [{'categories': [{'measurements': [{'value': '233.9', 'spread': '7.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^3 cells/cu mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood glucose', 'classes': [{'categories': [{'measurements': [{'value': '90.6', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood urea nitrogen', 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'total bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total protein', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Albumin', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sodium', 'classes': [{'categories': [{'measurements': [{'value': '140.5', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chloride', 'classes': [{'categories': [{'measurements': [{'value': '106.5', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Potassium', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total CO2', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calcium', 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '0.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anion gap', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-28', 'size': 755394, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-04T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomization will use an arm equivalence design to promote equal numbers of participants for each order schema.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2019-04-21', 'resultsFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2019-04-25', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-18', 'studyFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Human Plasma Concentration of Bioactives From Centella Asiatica.', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).'}, {'measure': 'Total Plasma Concentration Over Time (Area Under the Curve) From Centella Asiatica Water Extract Product.', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).'}, {'measure': 'Half-life', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'The half-life (t1/2) of the known bioactive compounds was calculated from the plasma concentrations measured by high performance liquid chromatography tandem mass spectrometry to help determine dosage intervals.'}, {'measure': 'Time of Maximum Concentration', 'timeFrame': 'A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).', 'description': 'The time of maximum concentration (tmax) of the known bioactive compounds and their metabolites will be calculated from the concentrations measured by high performance liquid chromatography tandem mass spectrometry in order to help determine dosage intervals'}], 'secondaryOutcomes': [{'measure': 'Urinary Excretion', 'timeFrame': 'Over 12 hours post-administration', 'description': 'The concentration of bioactive compounds from Centella asiatica (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in a pooled urine sample collected over 12 hours after CAP administration and analyzed using high performance liquid chromatography tandem mass spectrometry.'}, {'measure': 'Oral Temperature', 'timeFrame': '720 minutes after administration', 'description': 'Oral temperature will be measured in degrees Fahrenheit by means of a thermometer.'}, {'measure': 'Pulse Rate', 'timeFrame': '720 minutes after administration', 'description': 'Pulse rate will be measured peripherally over one minute.'}, {'measure': 'Seated Systolic Blood Pressure', 'timeFrame': '720 minutes after administration', 'description': 'Seated blood pressure will be measured in millimeters mercury.'}, {'measure': 'Body Mass Index', 'timeFrame': '720 minutes after administration', 'description': 'Height in centimeters and weight in kilograms will be measured and aggregated to measure body mass index in kilograms per meter squared (kg/m2).'}, {'measure': 'Participants With Change in Electrocardiography', 'timeFrame': '0, 360 and 720 minutes after administration', 'description': 'Resting electrocardiography will be measured for up to five minutes using a five lead mobile electrocardiogram. The investigators will determine the number of participants who develop changes in electrocardiography compared to the zero minute timepoint following CAP administration.'}, {'measure': 'Seated Diastolic Blood Pressure', 'timeFrame': '720 minutes after administration', 'description': 'Seated blood pressure will be measured in millimeters mercury.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Elderly']}, 'descriptionModule': {'briefSummary': 'This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract (CAW) product (CAP) in cognitively healthy elders.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\n1. To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in the plasma and urine of cognitively healthy elders over 12 hours.\n2. To determine the acute tolerability of a Centella asiatica product in cognitively healthy elders.\n\nOUTLINE:\n\nParticipants will orally consume a single administration of a standardized Centella asiatica water extract product (CAP). Two doses (2g and 4g CAW) will be administered on separate occasions, at least two weeks apart. The levels of known bioactive compounds present in Centella asiatica will be measured in human plasma and urine over 12 hours after administration of each of the doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 65-85, male and female\n2. Sufficient English language skills to complete all tests\n3. Sufficient vision and hearing to complete all tests\n4. No known allergies to Centella asiatica or CAP components\n5. Willingness to discontinue all botanical dietary supplements for one week prior to and during each study visit\n6. Willingness to comply with a 48-hour low plant diet for each study visit\n7. Absence of significant depression symptoms (Geriatric Depression Scale-15 score of \\<12)\n8. Body Mass Index (BMI) greater than 17 and less than 35 at screening\n9. Non-demented, defined as Clinical Dementia Rating (CDR) score of zero and Mini Mental State Examination (MMSE) score \\>28\n10. General health status that will not interfere with the ability to complete the study\n\nExclusion Criteria:\n\n1. Current smoking, alcohol or substance abuse according to DSM-V criteria\n2. Women who are pregnant, planning to become pregnant or breastfeeding\n3. Men who are actively trying to conceive a child or planning to within three months of study completion\n4. Severe aversion to venipuncture\n5. Abnormal laboratory evaluation indicating asymptomatic and untreated urinary tract infection\n6. Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade \\<3) and non-metastatic skin cancers\n7. Comorbid conditions such as diabetes mellitus, kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease\n8. Significant disease of the central nervous system such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke\n9. Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria\n10. Medications: sedatives (except those used occasionally for sleep), central nervous system active medications that have not been stable for two months (including beta blockers, cimetidine, SSRIs, SNRIs), anticoagulants (i.e. Warfarin), investigational drugs used within five half-lives of baseline visit, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotic analgesics, nicotine (tobacco, patches, gum, lozenges, etc.), Cannabis sativa (herb or edibles)\n11. Diseases associated with dementia such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus or Parkinson's disease with a CDR score \\>0.5 and MMSE score \\<28\n12. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements"}, 'identificationModule': {'nctId': 'NCT03929250', 'briefTitle': 'Pharmacokinetics of Centella Asiatica in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Pharmacokinetic Study of Centella Asiatica in the Elderly', 'orgStudyIdInfo': {'id': 'STUDY00017697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2g CAW Dose, then 4g CAW Dose', 'description': 'Participants first receive a single dose of a product containing 2g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of a product containing 4g CAW.', 'interventionNames': ['Drug: 2g Centella asiatica water extract product', 'Drug: 4g Centella asiatica water extract product']}, {'type': 'EXPERIMENTAL', 'label': '4g CAW Dose, then 2g CAW Dose', 'description': 'Participants first receive a single dose of a product containing 4g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of a product containing 2g CAW.', 'interventionNames': ['Drug: 2g Centella asiatica water extract product', 'Drug: 4g Centella asiatica water extract product']}], 'interventions': [{'name': '2g Centella asiatica water extract product', 'type': 'DRUG', 'otherNames': ['CAP 2g'], 'description': '2g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.', 'armGroupLabels': ['2g CAW Dose, then 4g CAW Dose', '4g CAW Dose, then 2g CAW Dose']}, {'name': '4g Centella asiatica water extract product', 'type': 'DRUG', 'otherNames': ['CAP 4g'], 'description': '4g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.', 'armGroupLabels': ['2g CAW Dose, then 4g CAW Dose', '4g CAW Dose, then 2g CAW Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University Department of Neurology', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Amala Soumyanath, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Department of Neurology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately after publication and for a period of 3 years following publication.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results reported in a publication after de-identification.', 'accessCriteria': 'Anyone who wishes access to the data, for any reason. Requests should be directed to Dr Amala Soumyanath at soumyana@ohsu.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amala Soumyanath', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}