Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-06 @ 3:03 AM
Study NCT ID:
NCT02392767
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2014-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020138', 'term': 'Hyperhomocysteinemia'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C068637', 'term': 'calcium D-pantothenate, L-cysteine drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'goyvaerts@loges.de', 'phone': '0049-4171-707182', 'title': 'Dr. Birgit Goyvaerts', 'organization': 'Dr. Loges + Co. GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.', 'otherNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks.\n\nPlacebo: corn starch', 'otherNumAtRisk': 25, 'otherNumAffected': 12, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cold', 'notes': 'common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'malaise', 'notes': 'stomach upset with diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'nasal mucosa disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'herpes NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'lumbago', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'generalized aching', 'notes': 'after gardening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cycling accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI")', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks.\n\nPlacebo: corn starch'}], 'classes': [{'categories': [{'measurements': [{'value': '0.070', 'groupId': 'OG000', 'lowerLimit': '-0.065', 'upperLimit': '0.205'}, {'value': '-0.052', 'groupId': 'OG001', 'lowerLimit': '-0.163', 'upperLimit': '0.060'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intervention period of 4 weeks', 'description': 'Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index ("lnRHI") which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side.\n\nNormal lnRHI \\> 0.51, Abnormal lnRHI \\< 0.51', 'unitOfMeasure': 'Delta lnRHI [Index]', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks\n\nPlacebo: corn starch'}], 'classes': [{'title': 'systolic reading', 'categories': [{'measurements': [{'value': '132.8', 'groupId': 'OG000', 'lowerLimit': '129.1', 'upperLimit': '136.6'}, {'value': '133.2', 'groupId': 'OG001', 'lowerLimit': '130.4', 'upperLimit': '136.1'}]}]}, {'title': 'diastolic reading', 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '79.8', 'upperLimit': '84.6'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '85.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intervention period of 4 weeks', 'description': 'The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks. Placebo: corn starch'}], 'classes': [{'categories': [{'measurements': [{'value': '9.10', 'groupId': 'OG000', 'lowerLimit': '8.30', 'upperLimit': '9.90'}, {'value': '11.95', 'groupId': 'OG001', 'lowerLimit': '11.19', 'upperLimit': '12.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After intervention period of 4 weeks', 'description': 'Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.\n\nThe first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)', 'unitOfMeasure': 'μmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks.\n\nPlacebo: corn starch'}], 'classes': [{'categories': [{'measurements': [{'value': '0.638', 'groupId': 'OG000', 'lowerLimit': '0.594', 'upperLimit': '0.682'}, {'value': '0.632', 'groupId': 'OG001', 'lowerLimit': '0.596', 'upperLimit': '0.668'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After intervention period of 4 weeks', 'description': 'ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test', 'unitOfMeasure': 'µmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks.\n\nPlacebo: corn starch'}], 'classes': [{'categories': [{'measurements': [{'value': '5.37', 'groupId': 'OG000', 'lowerLimit': '5.20', 'upperLimit': '5.54'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '5.19', 'upperLimit': '5.50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After intervention period of 4 weeks', 'description': 'Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.\n\nVerum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 times 2 tablets a day for 4 weeks\n\nPlacebo: corn starch'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '4.54'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '-1.31', 'upperLimit': '4.31'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intervention period of 4 weeks', 'description': 'Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the "percentage of the standard Quick value". In a person not receiving oral anticoagulation the "normal" Quick value is between 70 and 100%. The longer the patient\'s coagulation time, the lower the Quick value', 'unitOfMeasure': 'Percentage of the standard Quick value', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First Verum, Then Placebo', 'description': '2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.'}, {'id': 'FG001', 'title': 'First Placebo, Then Verum', 'description': '2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Cross-over study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'First Verum, Then Placebo', 'description': '2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.'}, {'id': 'BG001', 'title': 'First Placebo, Then Verum', 'description': '2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2014-11-14', 'resultsFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-03-18', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-29', 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase', 'timeFrame': 'Intervention period of 4 weeks', 'description': 'Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the "percentage of the standard Quick value". In a person not receiving oral anticoagulation the "normal" Quick value is between 70 and 100%. The longer the patient\'s coagulation time, the lower the Quick value'}], 'primaryOutcomes': [{'measure': 'Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI")', 'timeFrame': 'Intervention period of 4 weeks', 'description': 'Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index ("lnRHI") which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side.\n\nNormal lnRHI \\> 0.51, Abnormal lnRHI \\< 0.51'}], 'secondaryOutcomes': [{'measure': 'Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.', 'timeFrame': 'Intervention period of 4 weeks', 'description': 'The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.'}, {'measure': 'Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.', 'timeFrame': 'After intervention period of 4 weeks', 'description': 'Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.\n\nThe first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)'}, {'measure': 'Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.', 'timeFrame': 'After intervention period of 4 weeks', 'description': 'ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test'}, {'measure': 'Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.', 'timeFrame': 'After intervention period of 4 weeks', 'description': 'Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['L-Arginine', 'Pycnogenol', 'vitamin K2', 'vitamin B', 'endothelial function', 'hypertension', 'Homocystein >10'], 'conditions': ['Endothelial Dysfunction', 'Hyperhomocysteinemia', 'Hypertension Grade I, Subgroup "Borderline" (WHO)']}, 'referencesModule': {'references': [{'pmid': '28153005', 'type': 'DERIVED', 'citation': 'Reule CA, Goyvaerts B, Schoen C. Effects of an L-arginine-based multi ingredient product on endothelial function in subjects with mild to moderate hypertension and hyperhomocysteinemia - a randomized, double-blind, placebo-controlled, cross-over trial. BMC Complement Altern Med. 2017 Feb 2;17(1):92. doi: 10.1186/s12906-017-1603-9.'}]}, 'descriptionModule': {'briefSummary': 'The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.', 'detailedDescription': '25 patients were included in the trial. Intervention period was 4 weeks with 2 months wash out phase. The screening visit of all volunteers before study start included volunteer information, signature of informed consent, anamnesis, medical history, ECG and blood routine analysis.\n\nEfficacy parameters were measured at visit 1, 2, 3, and 4. Endothelial function and postprandial endothelial Reaction was tested using EndoPAT (validated diagnosis tool). Blood pressure was measured by volunteers over a period of 7 days before each visit. As additional parameters homocysteine and ADMA (assymmetric dimethyl arginine) were determed. For safety evaluation AEs (Adverse Events), CC (compliance control), tolerability, blood routine parameters and vital signs were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* borderline blood pressure (systolic 130-149)\n* homocystein level \\>10µmol/l\n\nExclusion Criteria:\n\ne.g.\n\n* BMI \\<20kg/m2 and \\>32kg/m2\n* use of antihypertensives, anticoagulants, and statins\n* cardiovascular diseases e.g. stroke, myocardial infarction\n* use of L-arginine and other dietary supplements'}, 'identificationModule': {'nctId': 'NCT02392767', 'briefTitle': 'Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Loges & Co. GmbH'}, 'officialTitle': 'Effect of a Dietary Supplement on Endothelial Function in Volunteers With Light to Moderate Hypertension - a Randomised, Double-blind, Placebo Controlled Cross-over Study', 'orgStudyIdInfo': {'id': 'BTS815/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verum', 'description': '2 times 2 tablets a day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Verum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 times 2 tablets a day which cornstarch. Tablets look identical like verum tablets.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Verum', 'type': 'DIETARY_SUPPLEMENT', 'description': '2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.', 'armGroupLabels': ['Verum']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'corn starch', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73728', 'city': 'Esslingen am Neckar', 'country': 'Germany', 'facility': 'BioTeSys', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}], 'overallOfficials': [{'name': 'Birgit Goyvaerts, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'medical advisor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Loges & Co. GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioTeSys GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}