Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-04 @ 9:11 AM
Study NCT ID:
NCT03143803
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2017-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Control of Blood Glucose Fluctuation With Usage of Polyherbal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-05', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean amplitude glycemic excursion', 'timeFrame': '14 days', 'description': 'To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days'}], 'secondaryOutcomes': [{'measure': 'Mean estimated glycated hemoglobin', 'timeFrame': '14 days', 'description': 'Mean estimated glycated hemoglobin difference between test and placebo control group'}, {'measure': 'Number of hypoglycemia episodes', 'timeFrame': '14 days', 'description': 'Number of hypoglycemia episodes and duration of hypoglycemia in treatment group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to get insight into control of glycemic variability with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.', 'detailedDescription': 'The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult males and non-pregnant females aged ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria\n\n1. Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND\n2. Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized within last 3 months.\n\nExclusion Criteria:\n\nAny one of the following\n\n1. Patients on Insulin therapy.\n2. Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.\n3. Women in child bearing age unable to practice any form of contraception\n4. Patients with diagnosis of Anemia (Hb\\<11 g/dl in Female and \\<13 g/dl in Male)\n5. Impaired renal function; estimated estimated glomerular filtration rate \\<60mls/min/1.73m2.\n6. Known history of any chronic illness taking regular pharmacological agents.\n7. Blood pressure fluctuations exceeding 20 mm of Hg on 2 subsequent clinic visits or known history of hypo tension or bradycardia in last 6 months or taking 3 or more anti-hypertensive medications regularly in the last 6 weeks\n8. Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy\n9. Current or former employees of organic India or any potential conflict of interest in participation\n10. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.\n11. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.'}, 'identificationModule': {'nctId': 'NCT03143803', 'briefTitle': 'Control of Blood Glucose Fluctuation With Usage of Polyherbal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Composite Interceptive Med Science'}, 'officialTitle': 'Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations', 'orgStudyIdInfo': {'id': 'OI-005-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Polyherbal', 'description': 'Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.', 'interventionNames': ['Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will contain an inert substance', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Polyherbal capsule coccinia, bougainvillea, catharanthus', 'type': 'DRUG', 'otherNames': ['Sugar Balance (SB)'], 'description': 'A unique combination of 3 herbs that lower blood sugars', 'armGroupLabels': ['Polyherbal']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Similar looking inactive powder', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560099', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mazumdar Shaw Medical Centre', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Alben Sigamani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Narayana Hrudayalaya Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Composite Interceptive Med Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}