Evaluation of the effect of Botox in addition to Diltiazem ointment in chronic anal fissure
Phase 3
- Conditions
- Chronic anal fissure.Chronic anal fissureK60.1
- Registration Number
- IRCT20151020024625N13
- Lead Sponsor
- Semnan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
A posterior or anterior linear ulcer with a skin tag
Induration of the wound edges
Visible internal sphincter muscle fibers in the base of wound
Pain and bleeding following defecation for at least 8 weeks
Exclusion Criteria
Fistula
Anal abscess
Symptomatic hemorrhoids
Acute fissure (less than eight weeks)
Irritable bowel syndrome
Anal surgery
pregnancy or lactation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of anal fissure. Timepoint: 3, 6, and 12 weeks after the intervention. Method of measurement: Physical examination.
- Secondary Outcome Measures
Name Time Method