Role of fiber supplementation in constipation.
Phase 4
- Conditions
- Health Condition 1: K590- Constipation
- Registration Number
- CTRI/2019/10/021687
- Lead Sponsor
- Dr Abhinav Jain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Diagnosed as chronic functional constipation on the basis of ROME-IV criteria
2. 18-80 years
3. willingness to participate in the study.
Exclusion Criteria
1.History of allergic reaction to any fiber supplementation
2. Celiac disease
3. Predominant bloating sensation
4. Severe constipation and failed previously on 2 or more laxatives
5. History of dysphagia, fecal impaction
6. Participant in another clinical study
7. Secondary causes of constipation detected
8. Patients with Irritable Bowel Syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool consistency: It will be measured by Bristol stool Form Scale <br/ ><br>Severity of constipation: The patients will be graded on PAC-SYM scoring system <br/ ><br>Patient satisfaction of bowel movements: Patient satisfaction with fibre supplementation will be assessed at the end of 4 weeks using a 5-point ordinal scale <br/ ><br>Quality of life: The quality of life will be assessed by the PAC-QoLTimepoint: Stool consistency: At baseline and 4 weeks <br/ ><br>Severity of constipation: At baseline and 4 weeks <br/ ><br>Patient satisfaction of bowel movements: Patient satisfaction with fibre supplementation will be assessed at the end of 4 weeks using a 5-point ordinal scale <br/ ><br>Quality of life: At baseline and end of 4 weeks
- Secondary Outcome Measures
Name Time Method SafetyTimepoint: Side effects will be graded