Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-04 @ 1:57 PM
Study NCT ID:
NCT02767869
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uiec@prodigy.net.mx', 'phone': '+52-33-10-58-52-00', 'title': 'Dr. Manuel González Ortiz', 'phoneExt': '34212', 'organization': 'Institute of Experimental andl Clinical Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the 12-week study.', 'eventGroups': [{'id': 'EG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'softening of stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pyrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Triglyceride Levels at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '148.0', 'spread': '43.0', 'groupId': 'OG000'}, {'value': '199.9', 'spread': '101.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '58.4', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.530', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Fasting Glucose Levels at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '103.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '104.2', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '116.3', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '122.6', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'First Phase of Insulin Secretion at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '913.9', 'spread': '490.3', 'groupId': 'OG000'}, {'value': '651.0', 'spread': '405.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.799', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Total Insulin Secretion at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Total Insulin Sensitivity at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity at week 12.", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Waist Circumference at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '97.0', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.919', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Waist circumference will be evaluated at baseline and at week 12 with a flexible tape', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'PRIMARY', 'title': 'Diastolic Blood Pressure at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.254', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Weight at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '72.6', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.347', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Body Mass Index at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '210.0', 'spread': '39.6', 'groupId': 'OG000'}, {'value': '201.7', 'spread': '34.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}, {'type': 'SECONDARY', 'title': 'Low-density Lipoprotein-cholesterol (LDL-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '20.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days\n\nBanaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days\n\nplacebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '45', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '78.8', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '77.6', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '28.6', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '97.0', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '97.4', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '97.2', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '121.5', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '122.6', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '122.0', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '81.7', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '79.1', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 0'", 'classes': [{'categories': [{'measurements': [{'value': '106.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '106.7', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '106.8', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 0 and 120 after a 75 g oral dextrose load.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Glucose 120'", 'classes': [{'categories': [{'measurements': [{'value': '131.3', 'spread': '27.2', 'groupId': 'BG000'}, {'value': '138.3', 'spread': '28.2', 'groupId': 'BG001'}, {'value': '134.8', 'spread': '55.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '217.5', 'spread': '48.3', 'groupId': 'BG000'}, {'value': '197.7', 'spread': '37.3', 'groupId': 'BG001'}, {'value': '207.6', 'spread': '42.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots to determine cholesterol', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '204.4', 'spread': '38.9', 'groupId': 'BG000'}, {'value': '200.8', 'spread': '80.6', 'groupId': 'BG001'}, {'value': '202.6', 'spread': '59.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine triglycerides', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein-cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '18.1', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '20.4', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '19.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into aliquots: the first was immediately analyzed to determine high-density lipoprotein-cholesterol (HDL-C)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein-cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '108.1', 'spread': '39.3', 'groupId': 'BG000'}, {'value': '108.0', 'spread': '35.3', 'groupId': 'BG001'}, {'value': '108.0', 'spread': '37.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine low-density lipoprotein-cholesterol (LDL-C).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Area under the curve (AUC) glucose', 'classes': [{'categories': [{'measurements': [{'value': '18567.6', 'spread': '3480.6', 'groupId': 'BG000'}, {'value': '19336.3', 'spread': '3224.7', 'groupId': 'BG001'}, {'value': '18951.9', 'spread': '3352.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The area under the curve (AUC) of glucose, (0.5 \\* glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 \\* G 120´) \\* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Area under the curve (AUC) insulin', 'classes': [{'categories': [{'measurements': [{'value': '8445.9', 'spread': '2384.8', 'groupId': 'BG000'}, {'value': '7669.7', 'spread': '2109.5', 'groupId': 'BG001'}, {'value': '8057.8', 'spread': '2247.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The area under the curve (AUC) of insulin, (0.5 \\* Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 \\* I 120´) \\* 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.', 'unitOfMeasure': 'uU*min/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very low-density lipoprotein (VLDL)', 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '40.5', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at baseline.', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'First phase of insulin secretion', 'classes': [{'categories': [{'measurements': [{'value': '954.3', 'spread': '285.3', 'groupId': 'BG000'}, {'value': '910.3', 'spread': '514.1', 'groupId': 'BG001'}, {'value': '932.3', 'spread': '399.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at baseline.", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Matsuda Index value is used to indicate insulin resistance on diabetes.\n\nInsulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity at baseline", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "Sample size was calculated in accordance of Jeyaseelan's clinical trial formula with a statistical confidence of 95%, statistical power of 80%, obtaining a total of 12 patients per group including 20% of expected loss."}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-25', 'studyFirstSubmitDate': '2016-05-06', 'resultsFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-25', 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride Levels at Week 12', 'timeFrame': 'Week 12', 'description': 'The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.'}, {'measure': 'High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12', 'timeFrame': 'Week 12', 'description': 'The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.'}, {'measure': 'Fasting Glucose Levels at Week 12', 'timeFrame': 'Week 12', 'description': 'The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12'}, {'measure': 'Systolic Blood Pressure at Week 12.', 'timeFrame': 'Week 12', 'description': 'The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12'}, {'measure': 'First Phase of Insulin Secretion at Week 12', 'timeFrame': 'Week 12', 'description': "Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12."}, {'measure': 'Total Insulin Secretion at Week 12.', 'timeFrame': 'Week 12', 'description': 'Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.'}, {'measure': 'Total Insulin Sensitivity at Week 12', 'timeFrame': 'Week 12', 'description': "Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity at week 12."}, {'measure': 'Waist Circumference at Week 12', 'timeFrame': 'Week 12', 'description': 'Waist circumference will be evaluated at baseline and at week 12 with a flexible tape'}, {'measure': 'Diastolic Blood Pressure at Week 12', 'timeFrame': 'Week 12', 'description': 'The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12'}], 'secondaryOutcomes': [{'measure': 'Weight at Week 12', 'timeFrame': 'Week 12', 'description': 'The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12'}, {'measure': 'Body Mass Index at Week 12', 'timeFrame': 'Week 12', 'description': 'The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12'}, {'measure': 'Total Cholesterol at Week 12', 'timeFrame': 'Week 12', 'description': 'The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12'}, {'measure': 'Low-density Lipoprotein-cholesterol (LDL-C) at Week 12', 'timeFrame': 'Week 12', 'description': 'The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'central obesity', 'Banaba', 'insulin secretion', 'insulin sensitivity'], 'conditions': ['Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '34726501', 'type': 'DERIVED', 'citation': 'Lopez-Murillo LD, Gonzalez-Ortiz M, Martinez-Abundis E, Cortez-Navarrete M, Perez-Rubio KG. Effect of Banaba (Lagerstroemia speciosa) on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2022 Feb;25(2):177-182. doi: 10.1089/jmf.2021.0039. Epub 2021 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.\n\nBanaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.\n\nThe investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.\n\n12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.\n\nThe remaining 12 patients received placebo with the same prescription.\n\nArea Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).\n\nThis protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.\n\nResults are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients both sexes,\n* Age between 30 and 60 years,\n* Metabolic Syndrome according to the IDF criteria\n* Waist circumference\n* Man ≥90 cm\n* Woman ≥80 cm\n\nAnd two of the following criteria:\n\n* High density lipoprotein\n* Man ≤40 mg/dL\n* Woman ≤50 mg/dL\n* Fasting glucose ≥100 mg/dL\n* Triglycerides ≥150 mg/dL\n* Blood pressure ≥130/85 mmHg\n* Informed consent signed\n\nExclusion Criteria:\n\n* Women with confirmed or suspected pregnancy\n* Women under lactation and/or puerperium\n* Hypersensibility to resveratrol\n* Physical impossibility for taking pills\n* Known uncontrolled renal, hepatic, heart or thyroid diseased\n* Previous treatment for the metabolic syndrome components\n* Body Mass Index ≥39.9 kg/m2\n* Fasting glucose ≥126 mg/dL\n* Triglycerides ≥500 mg/dL\n* Total cholesterol ≥240 mg/dL\n* Low density lipoprotein (c-LDL) ≥190 mg/dL\n* Blood Pressure ≥140/90 mmHg'}, 'identificationModule': {'nctId': 'NCT02767869', 'briefTitle': 'Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity', 'orgStudyIdInfo': {'id': 'BANABA-MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Banaba', 'description': 'Banaba capsules, 500mg, two times per day before meals during 90 days', 'interventionNames': ['Drug: Banaba']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Calcined magnesia capsules, 500mg, two times per day before meals during 90 days', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Banaba', 'type': 'DRUG', 'otherNames': ['Lagerstroemia speciosa'], 'description': 'Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.', 'armGroupLabels': ['Banaba']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['calcined magnesia'], 'description': 'Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45037', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'MANUEL GONZALEZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Manuel González Ortiz', 'investigatorAffiliation': 'University of Guadalajara'}}}}