Investigating the effect of topical diltiazem and botulinum toxin injection in the treatment of chronic anal fissure

Comparison of the effectiveness, recurrence rate and side effects of two therapeutic methods of Botulinum toxin injection and topical Diltiazem in the treatment of patients with chronic anal fissures

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230607058408N1

Enrollment

Registered

2023-06-29

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-07-25

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 one: Injection of 100 units of Botox in four divided doses of 25 units at 3, 6, 9 and 12 hours in the internal anal sphincter. Intervention 2: Intervention group two

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: People with chronic anal fissure between the ages of 18 and 80

Exclusion criteria

Exclusion criteria: Immune deficiency (using corticosteroids for more than 3 months, patients receiving transplants, receiving chemotherapy or radiotherapy, HIV positive patients with CD4 less than 200) Inflammatory bowel diseases Tuberculosis Recurrent anal fissure and complicated anal fissure (stenosis, abscess, fistula or hemorrhoids) Colon malignancy Pregnancy

Design outcomes

Primary

Measure	Time frame
Chronic anal fissure. Timepoint: Examination of anal fissure at the beginning of the study and 14 days later and at the end of the first, second, fourth and sixth months after the intervention. Method of measurement: Checklist and questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahime Mehrabi

Gonabad University of Medical Sciences

Fahimemehrabi99@gmail.com+98 51 5722 3028

Outcome results

None listed

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