Effects of Terminalia Chebula on hemorrhoids
Phase 3
Recruiting
- Conditions
- hemorrhoids.internal hemorrhoids without complications
- Registration Number
- IRCT2016101830372N1
- Lead Sponsor
- Vice chancellor for research, Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Inclusion criteria include 18 to 65 year-old women and men who have grade I and II hemorrhoids. Exclusion criteria include every severe disease; presence of cancer in every part of the body; every disease in anorectal except hemorrhoids; pregnant and lactating women; patients with history of using anticoagulant, antiplatelet drugs, steroids drugs, drugs with flavonoids (less than a month ago) and pain killers (less than a week ago).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bleeding of hemorrhoids. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: The number of days (questionnaire).;Pain. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Visual Analog Scale (VAS) (questionnaire).;The size of pilel mass. Timepoint: Before the intervention, and at the end of the intervention. Method of measurement: Rectosigmoidoscopy.;Constipation. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: ROM III criteria (questionnaire).;Exercise. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: At least half an hour daily for 4 days a week (questionnaire).
- Secondary Outcome Measures
Name Time Method Headache. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Visual Analog Scale (VAS) (questionnaire).;Vertigo. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Grading of vertigo severity (questionnaire).;Diarrhea. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Mild: <3 loose stools per day, Moderate: 3 to 10 per day, Severe: >10 per day (questionnaire).;Dry skin. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: skin dry grading scale (questionnaire).;Constipation. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: ROM III criteria (questionnaire).