A clinical study to see the effect of an Ayurvedic formulation in the patients of Irritable Bowel Syndrome

Phase 2

Recruiting

• Conditions: Irritable Bowel Syndrome

• Registration Number: CTRI/2012/01/002348
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

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 July-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.

Bilvadi Leha 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), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum) and Jirna Guda (Old Jaggery).

Bilvadi leha has been in use since ages, and has been found to be useful in treating Irritable Bowel Syndrome and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are  doing the clinical trials to scientifically study and validate the clinical efficacy and safety of this Ayurvedic formulation as a part of their Post Graduate (PG) Thesis.

The **Central Council for Research in Ayurvedic Sciences (CCRAS)** 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-20
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients of either sex with age between 18 and 65 years 2.
• 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) 3.
• Willing and able to participate in the study.

Exclusion Criteria

• Patients with bleeding per rectum.
• Mixed infection with parasites like round worms, hook worms etc.
• 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%}.
• 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.
• 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.
• 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.
• Alcoholics and/or drug abusers.
• H/o hypersensitivity to the trial drug or any of its ingredients.
• Pregnant / lactating woman.
• Patients who have completed participation in any other clinical trial during the past six (06) months.
• Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 16th week.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who achieve improvement in Diarrhoea / Constipation.	At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Trial Locations

Locations (3)

Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA); 🇮🇳 Jamnagar, GUJARAT, India

National Institute of Ayurveda (NIA); 🇮🇳 Jaipur, RAJASTHAN, India

Rajiv Gandhi Government Post-Graduate Ayurvedic College; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA)

🇮🇳Jamnagar, GUJARAT, India

Prof M S Baghel Ramanand Tiwari

Principal investigator

9427207964

baghelayu@rediffmail.com