Health Condition 1: K590- Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool consistency: It will be measured by Bristol stool Form Scale Severity of constipation: The patients will be graded on PAC-SYM scoring system 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 Quality of life: The quality of life will be assessed by the PAC-QoLTimepoint: Stool consistency: At baseline and 4 weeks Severity of constipation: At baseline and 4 weeks 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 Quality of life: At baseline and end of 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: Side effects will be graded | — |
Countries
India
Contacts
CIMS Hospital