CLINICAL EVALUATION OF KUTAJARISHTA IN THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME (IBS)

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1.Known case of IBS of subtype mixed( IBS-M) as per Rome III criteria :

Recurrent abdominal pain or discomfort for at least 3 months, and symptoms at least 3 days/month associated with two or more of the following:

•Relief of pain or discomfort with defecation.

•Onset of pain or discomfort associated with a change in form (appearance) of stool (loose or hard stools): Bristol stool form scale of type 1-2 for constipation and type 6-7 for diarrhoea.

•Onset of pain or discomfort associated with a change in bowel frequency: <= 3 bowel movements per week for constipation and > 3 bowels movements per day for diarrhoea.

2.Willing to give written informed consent for the participation.

Exclusion Criteria

1.Known cases of Gastroesophageal Reflux Disease(GERD)/hyperacidity

2.Patients with bleeding per rectum.

3.Mixed infection with parasites like round worms, hook worms etc.

4.Patients with evidence of malignancy

5.Patients with Diabetes Mellitus {B.S. (F) > 126 mg/dl and / or B.S. (2 hr. PP) >200 mg/dl

6.Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

7.Patients suffering from any systemic illness affecting the bowel habits as assessed by P.I.

8.Patient having history of unstable cardiovascular disease

9.Symptomatic patients with clinical evidence of heart failure.

10.Patients with concurrent 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),

Pulmonary Dysfunction (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 inflammatory bowel disease and coeliac disease.

13.Family history of gastrointestinal malignancy.

14.H/o hypersensitivity to the trial drug or any of its ingredients.

15.Pregnant / lactating woman.

16.Patients who have completed participation in any other clinical trial during the past six (06) months.

Any intestinal pathology which the Investigator thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the effect of Kutajarishta on IBS Severity scoreTimepoint: Time frame:from baseline to on 14th day,28th day,42th day,56th day,and 70th day, end of 12th week and 14th week)

Secondary Outcome Measures