Clinical Trial Details (PDF Generation Date :- Tue, 06 Nov 2018 17:15:59 GMT) CTRI Number Last Modified On 17/01/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/002377 [Registered on: 25/01/2012] - Trial Registered Retrospectively Yes Interventional Ayurveda Single Arm Trial A clinical study to see the effect of some Ayurvedic formulations in the management of Obesity Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Obesity (Sthaulya) 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 Janakpuri - Central Council for Research in Ayurvedic Opposite D Block, Janakpuri - Details Contact Person (Scientific Query) Janakpuri - Central Council for Research in Ayurvedic Opposite D Block, Janakpuri - Details Contact Person (Public Query) page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Janakpuri - Central Council for Research in Ayurvedic Opposite D Block, Janakpuri - Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. National Institute of Ayurveda (NIA), Jaipur. 2. Tilak Ayurved Mahavidyalaya, Pune. 3. Vaidyaratnam P. S. Varier Ayurved College, Kottakkal. Type of Sponsor List of Countries of Principal Investigator Prof Narainsingh Chundawat Dr Pankaj Dr S V Deshpande Dr Mrinmayi Baviskar Dr KV Dilipkumar Dr Deepti Nair Primary Sponsor Details Department of AYUSH Ministry of Health Family Welfare Government of Department of AYUSH, Ministry of Health & Family Welfare, Government of, IRCS Building, Red Cross Road, New Delhi-110001 Government funding agency of Site Site Phone/Fax/ National Institute of Ayurveda (NIA), Jaipur Tilak Ayurved Mahavidyalaya, Pune Department of Swasthavrutta, Amer Road, Madhav Vilas Palace, Jaipur-302002 Jaipur RAJASTHAN Department of Kayachikitsa,TAMV, 583/2, Rasta Peth, Pune-411011 Pune MAHARASHTRA Vaidyaratnam P. S. Department of Varier Ayurved College, Swasthavrutta, Kottakkal Kottakkal, P.O. Edarikode, Mallapuram-676501 Malappuram KERALA 9461624248 0141-2635709 nschundawat.nia@gmai l.com 9960071113 020-26336428 drsvdeshpande@yahoo.com 9847093321 0483-2751851 drdilipkv@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? page 2 / 5
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Committee, National Institute of Ayurveda (NIA), Jaipur Committee, Tilak Ayurved Mahavidyalaya, Pune Committee, VPSV Ayurved College, Kottakkal Status Health Type Patients Approved 09/11/2010 No Approved 07/09/2010 No Approved 15/10/2010 No Date No Date Specified Condition Obesity (Sthaulya) Type Details Intervention Vyoshadi Guggulu Dose 1.5 gm (3 Tablets)twice daily Dosage form - Tablet of 500 mg Route of Administration oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form- Bottle containg 60 tablets Duration of therapy-12 weeks Intervention Haritaki Churna Dose 3 gm twice daily Dosage form Sachet of 3 gm each Route of Administration Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-plastic jar containing 30 sachets Duration of therapy-12 weeks Comparator Agent Not applicable Not applicable Age From Age To Gender Details Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 1. Patients of either sex with age between 18 and 65 years. 2. BMI?30 kg/m2 and 3. Willing and able to participate in the study for 16 weeks. Exclusion Criteria 1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months. 2. Pathophysiologic/ genetic syndromes associated with obesity (Cushing s syndrome, Turner s syndrome, Prader willi syndrome). 3. Patients with evidence of malignancy 4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 6. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 7. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9. Symptomatic patient with clinical evidence of Heart failure. 10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study. 11. Alcoholics and/or drug abusers. 12. Prior surgical therapy for obesity 13. H/o hypersensitivity to any of the trial drugs or their ingredients. 14. Pregnant / lactating woman. 15. Patients who have completed participation in any other clinical trial during the past six (06) months. 16. Any other condition which the Principal Investigator thinks may jeopardize the study. Primary Outcome Outcome Timepoints Change in BMI At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. 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 Change in waist circumference and waist: hip ratio. Change in Lipid Profile. Change in quality of life SF-36 Scale Total Sample Size=150 Sample Size from =150 08/01/2011 No Date Specified Years=1 Months=6 Waist:Hip ratio is done At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end offollow up after 16th week. Lipid Profile is done Before and After treatment only wheres as, SF-36 is done at Baseline, at 84th day and after follow up of 16 weeks. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Days=0 Open to Recruitment To be published after the completion of the clinical trials in all the three centers. Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. Vyoshadi Guggulu is a poly herbal formulation containing Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Citraka (Plumbago zeylanica), Musta (Cyperus rotundus), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Vidanga (Embelia ribes) and Guggulu (Commiphora wightii). Haritaki Churna consists of dried pericarp of mature fruits of Terminalia chebula. Vyoshadi Guggulu and Haritaki Churna have been in use since ages and found to be useful in treating Obesity (Sthaulya) and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of these Ayurvedic formulations as a part of their Post Graduate (PG) Thesis. The is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. page 5 / 5