Effects of Psyllium seed husk powder vs. Polyethylene glycol on constipation in childre
Phase 3
Recruiting
- Conditions
- Constipation.Other functional intestinal disordes
- Registration Number
- IRCT2013021112437N1
- Lead Sponsor
- Vice chancellor for research of Kashan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Two to ten years old children who refer to children's clinic of Shahid Beheshti hospital with functional constipation, diagnosed based on the ROME III criteria. Exclusion criteria: Children beyond 2 and over 10 years old; use of other drugs that can cause constipation or diarrhea; or history of using pidrolax and probiotic in the last year.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation frequency. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Defecation without pain. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Drug admission. Timepoint: 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Defecation incontinency. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Adverse effects of drugs. Timepoint: 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.
- Secondary Outcome Measures
Name Time Method Early constipation relapse discontinue medication. Timepoint: 4 weeks after end of treatment. Method of measurement: Questionnaire that filling with parents.