A single arm clinical study :efficacy of kalyanaka guda in the management of the irritable bowel syndrome

Phase 3

• Conditions: Health Condition 1: K582- Mixed irritable bowel syndrome

• Registration Number: CTRI/2024/07/070131
• Lead Sponsor: ational Institute of Ayurveda, Deemed to be University, Jaipur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients between the age group of 18 to 60 years.

2.Patients irrespective of sex and socio- economic status.

3.Patients having signs and symptoms (abdominal pain and altered bowel habits) of

Irritable Bowel Syndrome and Vatika Grahani like parshvavankshanruk, chiraat dukham drav shushkam tanu..punah punah srujeta varchah..

Exclusion Criteria

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

2. Patients with bleeding per rectum.

3. Patients with evidence of malignancy.

4. Patients having concomitant illness like hypertension, diabetes mellitus type II,

Amoebic dysentery, Ulcerative colitis, Malabsorption syndrome,

Inflammatory Bowel Diseases & Intestinal tuberculosis, Lactase deficiency

diarrhoea.

5. Patients suffering from major systemic illness like cancer, crohn’s disease, renal

failure etc.

6. Patients who are taking corticosteroids, antidepressants, anticholinergic, or

any other drugs that may have an influence on the outcome of study.

7. Alcoholics and drug abusers.

8. Pregnant and lactating women.

9. Patients who have completed participation in any other clinical trial during the

past six months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the intensity of abdominal pain and altered <br/ ><br>bowel habits.Timepoint: At baseline and end of 28 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in the other symptoms(Bloating and Weakness) <br/ ><br>of IBS. <br/ ><br>Changes in quality of life. (QOL SF-36)Timepoint: At baseline and end of 28 days of treatment.