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1 Clinical Trial Details (PDF Generation Date :- Thu, 03 May :16:22 GMT) CTRI Number Last Modified On 29/03/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/03/ [Registered on: 30/03/2012] - Trial Registered Retrospectively No Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in the patients of Diabetes Mellitus. Clinical Evaluation of Saptavimshatika Guggulu and Haridra Churna in the Management of 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 Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. Ayurveda Central Research Institute (ACRI), Jaipur 2. Ayurveda Regional Research Institute (ARRI), Mandi 3. National Research Institute of Ayurvedic Drug Development (NRIADD), Bhubaneswar Type of Sponsor List of Countries of Principal Investigator Dr A K Jain Dr S K Sharma Dr Dip Sundar Sahu Primary Sponsor Details CCRAS, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy, New Delhi-, INDIA Research institution of Site Site Phone/Fax/ Ayurveda Central Research Institute (ACRI), Jaipur Ayurveda Regional Research Institute (ARRI), Mandi National Research Institute of Ayurvedic Drug Development (NRIADD), Bhubaneswar Ayurveda Central Research Institute, M. S. Central Research Institute (Ay.), Indira Colony, Bani Park, Jhotwara Road, Jaipur Jaipur RAJASTHAN Ayurveda Regional Research Institute, Gandhi Bhawan, Mandi Mandi HIMACHAL PRADESH vaidyaakjain@gmail.co m rrimnd@yahoo.com National Research Institute of Ayurvedic Drug Development, Unit drdssahu@gmail.com No.1, Bhubaneswar Khordha page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria ORISSA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, ACRI, Jaipur. Committee, ARRI, Mandi. Committee, NRIADD, Bhubaneswar. Status Health Type Patients Approved 20/04/2011 No Approved 21/03/2011 No Approved 21/04/2011 No Date No Date Specified Condition Type II Diabetes Mellitus Type Details Comparator Agent Intervention Age From Age To Gender Details Saptavimshatika Guggulu along with Haridra Churna Year(s) Year(s) Both Inclusion Criteria SAPTAVIMSHATIKA GUGGULU Dose 1gm (2 Tablets) twice daily; Dosage form - Tablet of 500 mg;route of Administration oral;time of Administration-Twice a day after food; Anupana-Lukewarm Water; Packing form- Bottle containg 60 tablets; Duration of therapy-12 weeks Along with HARIDRA CHURNA Dose-3 gm (1 sachet) twice daily; Dosage form-powder;route of Administration-oral; Time of Administration-Twice a day after food; Anupana-Luke warm Water; Packing form-plastic jar containing 90 grams of Haridra churna; Duration of therapy-12 weeks. Treatment naive patients or diagnosed patients of 1. Type II Diabetes Mellitus taking oral hypoglycemic drugs for? 6 weeks 2. Patients having Glycosylated haemoglobin (HbA1c)? 6.5%. 3. Willing and able to participate for 16 weeks Exclusion Criteria Details Exclusion Criteria 1. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc. 2. Patients suffering from brittle diabetes mellitus. 3. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Arrhythmia in the last 6 months. 4. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg) 5. Symptomatic patient with clinical evidence of Heart failure. 6. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 7. Pregnant / Lactating women. 8. Patient on steroids, oral contraceptive pills or estrogen replacement therapy. 9. Alcoholics and/or drug abusers. 10. Patients with evidence of malignancy 11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 12. H/o hypersensitivity to any of the trial drugs or their ingredients. 13. Patients who have completed participation in any other clinical trial during the past six (06) months. 14. Any other condition which the P.I. thinks may jeopardize the study. Primary Outcome Outcome Timepoints Change in Glycosylated haemoglobin (HbA1c%) At Baseline, on 42nd day and on 84th day Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial 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 Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) Change in Blood sugar Fasting. (10-12 hrs after dinner) Change in Blood sugar Post -Prandial. ( minutes after breakfast) Change in the SF-36-Health Survey Score Total Sample Size=150 Sample Size from =150 29/06/2011 No Date Specified Years=1 Months=0 Days=0 Open to Recruitment SF-36 done at Baseline, at 84th day and at the end of follow up after 14 weeks To be published after the completion of the clinical trials in all the three centers. page 4 / 5

5 Powered by TCPDF ( REF/2012/03/ Brief Summary The is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of. CCRAS is an apex body in for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine. Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of twenty five classical Ayurvedic formulations, multicentre clinical trials have been initiated in sixteen disease areas across nineteen peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program. This initiative is basically a supplement to the similar venture being worked out as an activity under the Ayurveda Clinical Trials (A.C.T.) project of the Ayurvedic Pharmacopoeia Committee (APC) wherein, clinical trials on eighteen disease conditions are underway in eight post graduate Ayurveda colleges across the country. Saptavimshatika Guggulu is a poly herbal preparation containing Shunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), kustha (Saussurea lappa), Vidanga (Embelia ribes), Guduci (Tinospora cordifolia), Citraka (Plumbago zeylanica), Sati (Hedychium spicatum), Sukshma ela (Elettaria cardamomum), Pippali mula (Piper longum), Hapusa (Juniperus communis), Devdaru (Cedrus deodara), Tejovati (Zanthoxylum aromaticum), Puskara (Saussurea lappa), Cavya (Piper chaba), Rakta indravaruni (Citrullus colocynthis), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Vid lavana, Saurvanchala lavana, Saindhava lavana, Yava kshara, Sarji kshara, Gaja pippali (Scindapsus officinalis) and Guggulu (Commiphora wightii). Haridra Churna is prepared by air drying the rhizomes of Haldi (Curcuma longa). The present study entitled Clinical Evaluation of Saptavimshatika Guggulu and Haridra Churna in the Management of Type II Diabetes Mellitus is being undertaken in three peripheral institutes of the CCRAS. The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations. page 5 / 5