Evaluation of the effect of Botox in addition to Diltiazem ointment in chronic anal fissure

Comparison of the effect of Botox and Botox in addition to Diltiazem ointment for the treatment of chronic anal fissure

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151020024625N13

Enrollment

Registered

2021-05-25

Start date

2021-06-22

Completion date

Unknown

Last updated

2021-05-26

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: For patients in the intervention group, 20 units of Botox will be injected by a 25 gauge needle into the internal sphincter at three and 9 o'clock (10 units per lo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Fistula Anal abscess Symptomatic hemorrhoids Acute fissure (less than eight weeks) Irritable bowel syndrome Anal surgery pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Degree of anal fissure. Timepoint: 3, 6, and 12 weeks after the intervention. Method of measurement: Physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Zahmatkesh

Semnan University of Medical Sciences

mehrdadzahmatkesh@semums.ac.ir+98 23 3142 2252

Outcome results

None listed

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