REF/2012/03/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Thu, 03 May :16:08 GMT) CTRI Number Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/04/ [Registered on: 16/04/2012] - Trial Registered Retrospectively No Interventional Single Arm Trial A clinical study to see the effect of an Ayurvedic formulation in the management of Irritable Bowel Syndrome Clinical Evaluation of Bilvadi Lehya in the Management of Irritable Bowel Syndrome (IBS) 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 Central Council for Research in Ayurvedic Sciences (CCRAS), Details Contact Person (Scientific Query) Central Council for Research in Ayurvedic Sciences (CCRAS), 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 Central Council for Research in Ayurvedic Sciences (CCRAS), Source of Monetary or Material Support > Support in terms of infrastructural facilities: 1. (ARRI), Jammu. 2. (ARRI), Mandi. 3. National Institute of Pharmaceutical Research (NIAPR), Patiala. Type of Sponsor List of Countries of Principal Investigator Dr Laxman Waman Bhurke Dr Om Raj Sharma Dr M M Rao Primary Sponsor Details Central Council for Research in Ayurvedic Sciences CCRAS, New Delhi-, INDIA Research institution of Site Site Phone/Fax/ (ARRI), Jammu (ARRI), Mandi National Institute of Pharmaceutical Research (NIAPR), Patiala, JDA Housing colony, Ban Talab, Rajender Nagar, Jammu Jammu JAMMU & KASHMIR Gandhi Bhawan, Mandi Mandi HIMACHAL PRADESH National Institute of Pharmaceutical Research (NIAPR), Moti Bagh Road, Patiala Patiala PUNJAB dewa2007@rediffmail.c om dr.omsharma.mandi@g mail.com meda_mrao@yahoo.co. in page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, NIAPR, Patiala, Punjab. Committee, ARRI, Mandi, Himachal Pradesh Committee,ARRI, Jammu Status Health Type Patients Approved 19/03/2011 No Approved 21/03/2011 No Approved 04/06/2011 No Date No Date Specified Condition Irritable Bowel Syndrome Type Details Comparator Agent Intervention Bilvadi Lehya Dose 10 gm twice daily Dosage form - Avleha Route of Administration Oral Time of Administration-Twice a day after food Anupana-Lukewarm Water Packing form- 300 gm pet jar Duration of therapy-12 weeks Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Details 1.Known case of IBS as per Rome III criteria : (Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for atleast six months, with symptoms experienced on atleast 3 days/month in the last 3 months associated with two or more of the following: Pain is relieved by defecation Onset associated with change of frequencey of stools Onset assoicated with a change in form (appearance) of stools. (Diagnosis to be confirmed by using the IBS module questionnaire) 2.Willing and able to participate in the study Details Exclusion Criteria 1. Patients with bleeding per rectum. 2. Mixed infection with parasites like round worms, hook worms etc. 3. Patients with evidence of malignancy 4. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)>200 mg% OR HbA1c> 6.5%}. 5. Patient with poorly controlled Hypertension (> 160 / 100 mm Hg) 6. Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, 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 page 3 / 5

4 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. H/o hypersensitivity to the trial drug or any of its ingredients. 13. Pregnant / lactating woman. 14. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Principal Investigator thinks may jeopardize the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Global Improvement in signs and symptoms of IBS (IBS severity score) At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th 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 Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Proportion of patients who achieve improvement in Diarrhoea /Constipation. Total Sample Size=150 Sample Size from =150 26/07/2011 No Date Specified Years=1 Months=0 Days=0 Open to Recruitment At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week. To be published after the completion of the clinical trials in all the three centers. The is an autonomous body under the Department of AYUSH (, 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 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 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 colleges across the country. Bilvadi Lehya is a poly-herbal preparation containing Bilva (Aegle marmelos), Musta (Cyperus rotundus), Dhanyaka (Coriandrum sativum), Jiraka (Cuminum cyminum), Sukshma ela (Elettaria cardamomum), Tvak (Cinnamomum zeylanicum), Nagkesara (Mesua ferrea), Shunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum) and Jirna Guda (Old Jaggery). The present study entitled Clinical Evaluation of Bilvadi Lehya in the Management of Irritable Bowel Syndrome is being undertaken in three peripheral institutes of the CCRAS. The same has been registered (Reg No. - CTRI/2012/01/002348) in the Clinical Trials Registry, (CTRI) as an activity under the ACT project. page 4 / 5

5 Powered by TCPDF ( REF/2012/03/ 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 this classical Ayurvedic formulation. page 5 / 5