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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190128042525N4
Enrollment
146
Registered
2020-11-02
Start date
2020-06-20
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic anal fissure. Chronic anal fissure

Interventions

Intervention 1: Intervention group: 100 g container contained Glyceryl trinitrate 0.2% -Ostrich oil 50% ointment will be prescribed for the patients. These drugs will be manufactured by Pasargad Rafsa

Sponsors

Rafsanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Taghizadeh

Rafsanjan University of Medical Sciences

clinical.research@rums.ac.ir+98 34 3428 0185

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026