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

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. 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:

Â· Pain is relieved by defecation

Â· Onset associated with change of frequencey of stools

Â· 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

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 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.

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) <br/ ><br>Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. <br/ ><br>

Secondary Outcome Measures

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