Effectiveness of Malakudaara Mezhugu in the management of Kattu Mantham (Functional Constipation)

Phase 2

• Conditions: Health Condition 1: K590- Constipation

• Registration Number: CTRI/2023/07/055098
• Lead Sponsor: Ayothidoss Pandithar Hospital, Ayothidoss Pandithar Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

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

Inclusion Criteria

Children with minimum two of the following clinical symptoms for atleast three month (Based on Rome IV criteria for Functional Constipation)

1) Straining during more than one-fourth (25%) of defecations

2) Lumpy or hard stools (Bristol Stool Form Scale 1 or 2) more than one-fourth (25%) of defecations

3) Sensation of incomplete evacuation more than one-fourth (25%) of defecations

4) Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations

5) Manual maneuvers to facilitate more than one-fourth (25%) of defecations (such as digital evacuation, or support of the pelvic floor)

6) Fewer than 3 Spontaneous Bowel Movements per week

7) Patientâ??s informant / Parent willing to sign the informed consent.

Exclusion Criteria

1) Intolerance to the drug and development of adverse reactions such as nausea, vomiting, abdominal discomfort during trial period.

2) Poor patient compliance & defaulters.

3) Patient turned unwilling to continue in the course of clinical trial.

4) Aggravation of symptoms.

Study & Design

• Study Type: Interventional
• Study Design: Not specified