A non-randomized control trial comparing the effects of topical Nifedipine oinment versus sphincterotomy surgery in the treatment of anal fissure.

A comparative study of topical 0.3% nifepidine with 1.5 % lidocaine versus lateral internal anal sphincterotomy in the management of anal fissure- a non randomised control trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085223

Enrollment

144

Registered

2025-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: K602- Anal fissure, unspecified

Interventions

Intervention1: topical Nifedipine (0.3 % w/w) and lidocaine (1.5 % w/w) oinment: Patients belonging to Group A (intervention group) will be treated with topical Nifedipine (0.3 % w/w) and lidocaine (1

Eligibility

Inclusion criteria

Inclusion criteria: 1)Acute anal fissure 2)Chronic anal fissure 3)Reccurrent anal fissures

Exclusion criteria

Exclusion criteria: 1)Fissures with hemorrhoids and fistula-in-ano. 2)Fistula-in-ano. 3)Fissures associated with malignancies.

Design outcomes

Primary

Measure	Time frame
To Compare the pain using visual analogue scale in patients with anal fissures attending general surgery outpatient department with age more than 18years treated with Topical 0.3% Nifedipine Ointment WITH 1.5% LIDOCAINE and Lateral anal Sphincterotomy at the end of 12 weeks.Timepoint: Till the end of 12 weeks.	—

Secondary

Measure	Time frame
To compare the healing in patients with anal fissures , attending general surgery outpatient department with age more than 18years treated by Topical 0.3% Nifedipine Ointment with 1.5% Lidocaine and Lateral anal Sphincterotomy at the end of 12 weeks.Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDivin George Jose

Pondicherry institute of medical sciences

divingeorge31071999@gmail.com8148658558

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026