A Clinical trial to study effect of Ayulax Capsule in the Management of Functional Constipatio

Phase 3

Completed

• Conditions: Health Condition 1: null- Functional Constipation

• Registration Number: CTRI/2015/01/005349
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis

a. Straining during at least 25 percent of defecations

b. Lumpy or hard stools at least 25 percent of defecations

c. Sensation of incomplete evacuation at least 25 percent of defecations

d. Sensation of anorectal blockage at least 25 percent of defecations

e. Manual maneuvers to facilitate at least 25 percent of defecations

f. Fewer than three defecations per week

2. Subjects having stool form between 1 to 3 on the Bristol Stool Form Scale

Exclusion Criteria

1. Subjects with diagnosed colonic inertia.

2. Subjects who have recently undergone abdominal surgery

3. Subjects with history of anorectal surgery.

4. Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e. IBS, Belching disorders etc.)

5. Subjects with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis.

6. Subjects with renal or liver dysfunction

7. Pregnant or lactating females

8. Subjects with disturbed thyroid functions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of Ayulax Capsule in the Management of Functional Constipation by assessing changes in frequency of bowel movementsTimepoint: 14 days and 21 days

Secondary Outcome Measures

Name	Time	Method
1. Changes in stool form <br/ ><br>2. Changes in symptoms of functional constipation <br/ ><br>3. Changes in associated clinical symptoms <br/ ><br>4. Global assessment for overall improvement by the physician <br/ ><br>5. Global assessment for overall improvement by the Patient <br/ ><br>6. Tolerability of drug by the physician and by patient <br/ ><br>7. Adverse events <br/ ><br>8. Laboratory parameters <br/ ><br>Timepoint: 14 days and 21 days