The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure: a randomized, double-blind clinical trial study

Phase 3

Recruiting

• Conditions: chronic anal fissure.; Chronic anal fissure; K60.1

• Registration Number: IRCT20190128042525N4
• Lead Sponsor: Rafsanjan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Patients with symptoms of the disease such as pain or bleeding during defecation which was lasting for at least 8 weeks.
Patients having anorectal region's posterior or anterior wound in examination in lithotomy position, which is associated with skin tag. Also horizontal smooth muscle fibers are visible at the base of the wound and sphincter is hypertrophic.

Exclusion Criteria

Patients with other anorectal diseases such as hemorrhoids, fistulas and abscesses, diabetes, tuberculosis, Crohn's and ulcerative colitis, anorectal neoplasm, leukemia and STDs such as AIDS and syphilis.
Patients with history of anal surgery
Patients with history of medical treatment of chronic anal fissure
Patients who underwent pelvic radiotherapy
Patients who are receiving chemotherapy or using immunosuppressive drugs
Patients with anal incontinence
Patients without medical treatment compliance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scoring. Timepoint: Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th & 16th weeks after intervention. Method of measurement: Visual Analogue Scale Questionnaire.;Wound grading. Timepoint: Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th & 16th weeks after intervention. Method of measurement: By means of physical examination and grading: grade I (fresh wound with inflammation), grade II (wound with granulation tissue) and grade III (wound covered with complete epithelial tissue).;Bleeding grading. Timepoint: Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th & 16th weeks after intervention. Method of measurement: By means of history taking : grade I (there is no bleeding during defecation), grade II (sometimes there is bleeding during defecation) and grade III (there is always bleeding during defecation).

Secondary Outcome Measures

Name	Time	Method
Quality of life score. Timepoint: After complete recovery of the patient and cessation of treatment. Method of measurement: Completing the World Health Organization's (26-Question) Quality of Life Questionnaire.;Recurrence of the disease. Timepoint: At the end of 8th & 16th weeks of follow up period. Method of measurement: By history taking and physical examination.