REF/2011/11/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Fri, 24 Nov :47:32 GMT) CTRI Number Last Modified On 15/01/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/12/ [Registered on: 05/12/2011] - Trial Registered Retrospectively Yes Interventional Drug Ayurveda Randomized, Parallel Group Trial effect of Triphaladi Granules on Diabetes A Clinico-experimental Study on Triphaladi Granules in Apathyanimittaja Prameha (Type II Diabetes Mellitus) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator Ankush Gunjal MD Scholar Phone Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University dr.ankush30@gmail.com Details Contact Person (Scientific Query) Prof HM Chandola Prof and Head Phone Dept of Kayachikitsa Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University drhmchandola@yahoo.com Details Contact Person (Public Query) Prof HM Chandola Prof and Head Dept of Kayachikitsa Gujarat Ayurved University Phone page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria > Gujarat Ayurved University Type of Sponsor List of Countries of Principal Investigator drhmchandola@yahoo.com Source of Monetary or Material Support Primary Sponsor Details Gujarat Ayurved University Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Gujarat Research institution and hospital of Site Site Phone// Dr Ankush Gunjal OPD and IPD Dept of Kayachikitsa Gujarat Ayurved University dr.ankush30@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee, Status Health Type Patients Approved 05/09/2010 Yes Date No Date Specified Condition Patients suffering from Prameha ( Diabetes Mellitus ) Type Details Intervention Triphaladi Granules 5 g BD with Lukewarm water along with exercise and Pathya for 2 months Comparator Agent Any allopathic medicine dose as recommended by modern physician along with Triphaladi granules (5 g BD with lukewarm water) exercise and Pathya, 2 months Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Known patient of Type II Diabetes mellitus, and also the patients preliminarily diagnosed Type II Diabetes mellitus on the basis of signs and symptoms of the disease will be confirmed by FBS and PPBS and then will be included in study. Patients presenting with Type2 DM having, Random serum glucose level of greater than 200 mg/dl. Fasting Blood Sugar greater than 126 mg/dl page 2 / 5

3 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Patients of Type2 Diabetes mellitus under Modern medication. Exclusion Criteria 1. Age below 30 years & above 70 years. 2.Patients of Sahaja Prameha and having bala and dhatukshaya (gestational diabetes mellitus) and Type I Diabetes mellitus. 3.Patient having any one of following condition. Malignant and accelerated hypertensive CVS disorder (CAD) Pregnant woman and planning to be pregnant within six months Lactating mother Secondary Diabetes mellitus,diabetic ketosis CNS disorder e.g. encephalopathy Patient under going regular treatment for any other severe illness and also patients suffering from Tuberculosis, Carcinoma and HIV positive patients. will be excluded for the present study including endocrinal disorders like, Thyrotoxicosis, Cushing Syndrome etc. Primary Outcome Outcome Timepoints The efficacy of treatment will be assessed on the basis of relief in signs and symptoms. Evaluation of biochemical parameters such as FBS, PPBS in both groups along with Hematological, Urine routine and microscopic examination before and after the treatment. S. Insulin and Glycosulated haemoglobin before and after the treatment.(if possible ) At interval of one month and of two months the Evaluation of biochemical parameters such as FBS, PPBS in both groups along with Hematological, Urine routine and microscopic examination before and after the treatment. S. Insulin and Glycosulated haemoglobin before and after the treatment.(if possible ) and The efficacy of treatment will be assessed on the basis of relief in signs and symptoms. Secondary Outcome Outcome Timepoints Target Sample Size exacerbation in signs and symptoms Total Sample Size=50 Sample Size from =50 Phase of Trial Phase 1/ Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details 03/11/2011 No Date Specified Years=1 Months=3 Days=0 Completed nil 4 weeks Brief Summary The present study is designed with the aims to study etiopathogenesis of Apathyanimittaj prameha and Type 2 Diabetes Mellitus, to study the antidiabetic effect of Ayurvedic formulation Triphaladi granules in general and in those diabetic patients who are already under modern medication and to study the effect of Triphaladi granules for hypoglycemic and antihyperglycemic activities in experimental animals. page 3 / 5

4 Triphaladi Granules consists of powders of Triphala, Asana, Kalinga, Musta and Daruharidra in granule form. v Group A: Recently diagnosed patients, mild to moderate cases of type II Diabetes - Apathya Nimittaja Prameha will be administered Triphaladi granules along with pathyapalana ie. Controlled diet and exercise. v Group B: known patients of Type II Diabetes mellitus with ongoing mordern antidiabetic drugs, whose blood glucose level is not well under control will be administered with Triphaladi granules additionally along with pathyapalana. DRUG, DOSE & DURATION: Drug : - Triphaladi granules Dose : - 5 gm two times a day before meals Anupana: - Luke warm water Duration: - 2 months ( For group A & B ) page 4 / 5

5 Powered by TCPDF ( REF/2011/11/ CRITERIA FOR ASSESSMENT: The efficacy of treatment will be assessed on the basis of relief in signs and symptoms. Evaluation of biochemical parameters such as FBS, PPBS in both groups along with Hematological, Urine routine and microscopic examination before and after the treatment. S. Insulin and Glycosulated haemoglobin before and after the treatment.(if possible ) FOLLOW UP: Follow up will be done for four weeks after the completion of treatment to see the long standing effect of the drug. Patients will be redirected to regular OPD treatment after the stipulated time of research work. page 5 / 5