A study to investigate the effect of Brihat Gangadhar Churna in the treatment of Irritable bowel syndrome

Phase 2

Recruiting

• Conditions: Irritable Bowel Syndrome

• Registration Number: CTRI/2016/01/006550
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India 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 classical Ayurvedic formulations, multicentre clinical trials have been initiated in peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program.

Brihat Gangadhara Churna is a poly-herbal preparation containin:

Bilva (Aegle marmelos),Musta (Cyperus rotundus), Shunthi (Zingiber officinale),Dhataki(woodfordia fruticosa),Araluka(Ailanthus excels),Lodhra(Symplocos racemosa), Balak(Pavonia odorata), Mocharasa(Salmalia malabarica),Patha(Cissampelos pareira),Indrayava (Holarrhena antidysentrica),Vatsaka(Holarrhena  antidysentrica), Amrabeeja(Mangifera indica),Ativisa(Aconitum heterophyllum),Lajjalu(Mimosa pudica).The present study entitled

**“Clinical efficacy and safety of Brihat Gangadhara Churna in the management of Irritable Bowel Syndrome.â€** is being undertaken in one peripheral institute 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 this classical Ayurvedic formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-05
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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 at least six months, with symptoms experienced on at least 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 frequency of stools (Constipation: < 3.
• week, diarrhoea > 3/days Onset associated with a change in form (Bristol Stool chart Type 1-2 constipation, Type 6-7 diarrhea. 2. Willing and able to participate in the study for 14 weeks.

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% 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 any systemic illness affecting the bowel habits as assessed by PI.
• 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 >1.4mg/dL), 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	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 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 14th week.

Trial Locations

Locations (1)

National Research Institute of Ayurvedic Drug Development (NRIADD) , Kolkata, West Bengal; 🇮🇳 Kolkata, WEST BENGAL, India

National Research Institute of Ayurvedic Drug Development (NRIADD) , Kolkata, West Bengal

🇮🇳Kolkata, WEST BENGAL, India

Dr Debajyoti Das

Principal investigator

033-23673808

debajyoti.das02@gmail.com