A clinical trial to compare the effects of Unani research drug Qurs Mulaiyin with allopathic drug Dulcolax in patients with difficulty in passage of stool

Phase 2

• Conditions: Health Condition 1: K590- Constipation

• Registration Number: CTRI/2023/01/049032
• Lead Sponsor: Central Council for Research in Unani Medicine (CCRUM), New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Participants of either sex in the age group 18 to 65 years.

2. Patients meeting the Rome III diagnostic criteria for functional constipation which were fulfilled for the past 3 months with symptoms onset at least 6 months before diagnosis:

Must include two or more of the following:

a. Straining during at least 25% of defecations

b. Lumpy or hard stool in at least 25% of defecations

c. Sensation of incomplete evacuation for at least 25% of defecations

d. Sensation of anorectal obstruction/blockage for at least 25% of defecations

e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)

f. Fewer than three defecations per week

2. Loose stool being rarely present without the use of laxatives

3. Insufficient criteria for irritable bowel syndrome.

Exclusion Criteria

1. Patients on chronic laxative medication ( >60 days) and/or who were on medications known to cause constipation (like opioid analgesics, antidepressants, anticonvulsants) were excluded.

2. Known case of a megacolon/megarectum.

3. Known cases of HIV/AIDS, cancer, etc.

4. Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.

5. Known hypersensitivity to study drug or any of its ingredients

6. Pregnant and Lactating females

7. Uncontrolled Diabetes Mellitus

8. Any systemic disorder requiring prolonged treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of Daimi Qabz (Chronic constipation)Timepoint: 1 week

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessment for safety assessmentTimepoint: 1 week