Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
Study NCT ID:
NCT03531203
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2018-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058246', 'term': 'Prehypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline morning home blood pressure at week 7 and 13', 'timeFrame': 'Week 0, 7 and 13', 'description': "Blood pressure was measured by medical team using Omron HEM-907 (digital automatic blood pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home. Subjects were examined in sitting position."}, {'measure': 'Change in baseline serum uric acid at week 7 and 13', 'timeFrame': 'Week 0, 7 and 13', 'description': 'Blood sample was taken to measure serum uric acid level'}], 'secondaryOutcomes': [{'measure': 'Change in baseline CKD-Epi at week 7 and 13', 'timeFrame': 'Week 0, 7 and 13', 'description': 'Measurement of glomerular filtration rate'}, {'measure': 'Change in baseline uric acid excretion at week 7 and 13', 'timeFrame': 'Week 0, 7 and 13', 'description': '24-h urine sample was taken to measure uric acid excretion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['soursop', 'supplementation', 'prehypertension', 'uric acid', 'randomized controlled trial'], 'conditions': ['Blood Pressure', 'Prehypertension', 'Uric Acid']}, 'descriptionModule': {'briefSummary': "This study was a randomized controlled trial study. The aim of this study was to determine the effect of soursop fruit supplementation on blood pressure (BP), serum uric acid (SUA), and kidney function.\n\nThe definition of prehypertension and hypertension was accepted as delivered in The Seventh Report of the Joint National Committee (JNC 7) as the systolic BP was 120 - 139 mmHg and diastolic BP was 80 - 89 mmHg for prehypertension, while systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg for hypertension.\n\nBased on the study by Sja'bani (2014), the cut-off point of (SUA) was divided into 3 categories, which are normal (\\< 5 mg/dL), high-normal (5 - \\<7 mg/dL), and high (≥ 7 mg/dL).\n\nA number of 143 people with essential prehypertension and high normal uric acid level were assigned as subject in this study. Subjects were randomly assigned into two groups which are treatment and control group. For a 3 months period, the treatment group was given 2x100 g soursop fruit juice per day and the control group was left without treatment.\n\nBlood pressure was measured by medical team using Omron HEM-907 (digital automatic blood pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home. Subjects were examined in sitting position. Evaluation of laboratory examination was taken at week 0, 7 and 13."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pre-hypertensive patients in accordance with JNC 7 (Joint National Committee 7) criteria,\n2. male or female resident in Mlati, Sleman with or without family history of hypertension,\n3. age 30-59 years,\n4. high normal uric acid levels (≥ 5 and \\< 7 mg/dL) and\n5. agreed to follow the study by giving their informed consent.\n\nExclusion Criteria:\n\n1. have a history of diabetes, chronic renal failure,\n2. using hormonal contraceptive,\n3. in pregnancy,\n4. taking uric acid-lowering drugs (allopurinol, probenecid),\n5. positive urine reduction, positive proteinuria, creatinine \\> 1.5 g/dL, Blood Glucose \\> 126 g/dL.'}, 'identificationModule': {'nctId': 'NCT03531203', 'briefTitle': 'The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'The Effect of Soursop Supplementation on Blood Pressure, Serum Uric Acid and Kidney Function in Prehypertensive Patients', 'orgStudyIdInfo': {'id': 'Soursop Supplementation 2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With Soursop', 'description': 'Treatment group (with soursop group) was a group which receive soursop supplementation', 'interventionNames': ['Dietary Supplement: Soursop supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Without Soursop', 'description': 'Control group (without soursop group) was a group which do not receive any intervention (placebo)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Soursop supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The soursop supplementation was given to treatment group (with soursop group) 2 times a day for 100 g each for 3 months period.', 'armGroupLabels': ['With Soursop']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Control group (without soursop group) was left without treatment during study period', 'armGroupLabels': ['Without Soursop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55284', 'city': 'Sleman', 'state': 'Special Region of Yogyakarta', 'country': 'Indonesia', 'facility': 'Mlati 2 Health Center working area (Sumberadi, Tlogoadi,Tirtoadi)', 'geoPoint': {'lat': -7.71556, 'lon': 110.35556}}], 'overallOfficials': [{'name': "Mochammad Sja'bani, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Faculty of Medicine, University of Gadjah Mada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mlati Study Group, Faculty of Medicine, Gadjah Mada University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Mochammad Sja'bani", 'investigatorAffiliation': 'Gadjah Mada University'}}}}