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Anti-fissure cream and diltiazem gel on anal fissure

Comparison of The efficacy of Anti-fissure barij cream and diltiazem gel in severity of pain, bleeding and healing of anal fissure

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210110049992N1
Enrollment
80
Registered
2025-02-18
Start date
2025-03-09
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Anal fissure. Anal fissure, unspecified

Interventions

Intervention 1: Intervention Group A: Receives Barriage Essence company's Antifischer cream, applied twice daily using an applicator at the anal site. The cream will be provided in 50-gram tubes, unif

Sponsors

barijessence company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with acute fissure Age more than 15 years old

Exclusion criteria

Exclusion criteria: Hemorrhoid Anal fistula Anal abcess Pregnancy Breastfeeding Malignancy

Design outcomes

Primary

MeasureTime frame
Anal fissure grade after treatment. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after treatment. Method of measurement: Clinical examination by a physician and decisions based on the following grades:Grade 0: HealedGrade 1: Fissure with visible internal anal sphincterGrade 2: Deeper fissures with more extensive visibility of the internal anal sphincterGrade 3: Fissure with indeterminate depthGrade 4: Accompanied by perianal fistula.

Secondary

MeasureTime frame
Hemorrhage grade. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment initiation. Method of measurement: Asking the patient: Score 0: No bleedingScore I (mild): Presence of blood streaks in stoolScore II (moderate): Intermittent bleeding during defecationScore III (severe): Continuous bleeding during defecation.;Pain severity during defication. Timepoint: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks after treatment initiation. Method of measurement: Pain Severity: Numeric Rating Scale (NRS-11) - This is a patient-reported scale used for adults and children aged 10 years or older. It is defined as follows:Score 0: No painScore 1-3: Mild pain (annoying but causes little interference with daily activities)Score 4-6: Moderate pain (significantly interferes with daily activities)Score 7-10: Severe pain (disabling and unable to perform daily activities).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbdolhosein Davoodabadi

Kashan University of Medical Sciences

Davoodabadi-A@kaums.ac.ir+98 31 5547 2939

Outcome results

None listed

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