Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03884920
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2019-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-20', 'size': 210756, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-21T06:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-19', 'studyFirstSubmitDate': '2019-03-15', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Liver Functions', 'timeFrame': 'six week', 'description': 'Serum Glutamate pyruvate transaminase (SGPT) (mg/dl)'}, {'measure': 'Liver Function', 'timeFrame': 'six week', 'description': 'serum glutamate oxaloacetate transaminase (SGOT)(mg/dl)'}, {'measure': 'Liver Function', 'timeFrame': 'six week', 'description': 'Alkaline phosphatase (ALP)'}, {'measure': 'Kidney Function', 'timeFrame': 'six week', 'description': 'Serum creatinine (mg/dl)'}, {'measure': 'Kidney Function', 'timeFrame': 'six week', 'description': 'Blood Urea Nitrogen (mg/dl)'}], 'primaryOutcomes': [{'measure': 'Fasting Glucose Tolerance (FGT)', 'timeFrame': 'six weeks', 'description': 'enhancement of fasting glucose tolerance (\\<100mg/dl)'}, {'measure': 'Glucose Tolerance (GT)', 'timeFrame': 'six weeks', 'description': 'enhancement of oral glucose tolerance (\\<140mg/dl)'}, {'measure': 'HB-A1c', 'timeFrame': 'six week', 'description': 'improvement in glycated hemoglobin (HB-A1c) percentage \\<6%,'}], 'secondaryOutcomes': [{'measure': 'Lipid Profile', 'timeFrame': 'six weeks', 'description': 'serum Cholesterol level (mg/dl)'}, {'measure': 'Lipid Profile', 'timeFrame': 'Six Weeks', 'description': 'Serum Triglycerides (mg/dl)'}, {'measure': 'Lipid Profile', 'timeFrame': 'Six week', 'description': 'Serum Low Density Lipids (LDL) (mg/dl)'}, {'measure': 'Lipid Profile', 'timeFrame': 'six week', 'description': 'Serum High Density Lipids (HDL) (mg/dl)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Impaired Fasting Glucose', 'Impaired Glucose Tolerance', '2hr -75gm Oral Glucose Tolerance Test', 'Diabetes Mellitus Prevention'], 'conditions': ['Diabetes Mellitus', 'Pre Diabetes']}, 'descriptionModule': {'briefSummary': 'Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.', 'detailedDescription': 'This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.\n\nvolunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.\n\nOn screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.\n\nBiochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.\n\nCollected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* community samples will be obtained from the area of Bahawalpur\n* Model Town A, B, and\n* remote areas of district Bahawalpur consisting of Khairpur Tamewali city population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-59\n* Impaired Fasting Glucose (100-125mg/dl)\n* Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT\n* History of Diabetes in first degree relation with one condition\n* At high risk with BMI \\> 35%\n* Early onset diabetic / accidental on screening (glucose \\>200mg/dl)\n\nExclusion Criteria:\n\n* on renal dialysis;\n* an acute or terminal illness or serious mental illness;\n* history of recent coronary event within the last 12 months;\n* a recent history of acute medical problem or admission to hospital;\n* any other severe medical conditions that need intervention / treatment\n* has poor short-term prognosis (expected death in \\<2 years);\n* is planning to travel for longer than 6 weeks during the 6-week intervention period; or\n* is with compromised liver / kidney / cardiac function\n* older patients of DM taking any form of medication / intervention'}, 'identificationModule': {'nctId': 'NCT03884920', 'acronym': 'Phase-1', 'briefTitle': 'Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation', 'organization': {'class': 'OTHER', 'fullName': 'Islamia University of Bahawalpur'}, 'officialTitle': 'Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine', 'orgStudyIdInfo': {'id': 'Hashmi5767'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A Pre-diabetic placebo', 'description': 'Group of pre-diabetics receiving placebo BD for six weeks'}, {'label': 'Group B Pre-diabetic test', 'description': 'Group of Pre-diabetic receiving polyherbal / test candidate 900mg in two divided doses for six weeks', 'interventionNames': ['Dietary Supplement: Polyherbal formulation']}, {'label': 'Group C Diabetic test', 'description': 'Early onset of Diabetes mellitus receiving polyherbal formulation 1800mg in two divided doses for six weeks', 'interventionNames': ['Dietary Supplement: Polyherbal formulation']}], 'interventions': [{'name': 'Polyherbal formulation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Test candidate will be administered per oral before / with meal in two divided doses', 'armGroupLabels': ['Group B Pre-diabetic test', 'Group C Diabetic test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63060', 'city': 'Khairpur Tamewali', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Hashmi Dawakhana', 'geoPoint': {'lat': 29.58258, 'lon': 72.2423}}, {'zip': '63100', 'city': 'Bahawalpur', 'country': 'Pakistan', 'facility': 'University College of Conventional Medicine', 'geoPoint': {'lat': 29.39779, 'lon': 71.6752}}], 'overallOfficials': [{'name': 'H A Sattar Hashmi, M.Phil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'scholar'}, {'name': 'Dr K A.Ansari, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Islamia University of Bahawalpur', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hashmi Herbal Pharma (HHP) Registered Bahawalpur', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hafiz Abdul Sattar Hashmi', 'investigatorAffiliation': 'Islamia University of Bahawalpur'}}}}