Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: 0.3% nifedipine and 2% lidocaine ointment.: topical medication two times daily for a minimum of 6 weeks. The application will be done by the patient with the tip of their index finger (
Sponsors
AIIMS Delhi
Eligibility
Inclusion criteria
Inclusion criteria: with a definitive diagnosis of anal fissure
Exclusion criteria
Exclusion criteria: 1. History of reaction to topical agents. 2. Recurrent anal fissures 3. Associated condition or disease such as severe anaemia, cancer, fistula, abscess, Crohnâ??s disease, HIV related anal ulcer, tuberculosis ulcer, leukemic ulcer, pregnancy, third and fourth degree haemorrhoids, and Diabetes mellitus 4. History of surgical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact on quality of life using REALISE score of patients with anal fissure comparing Nifedipine ointment with Lidocaine vs. Diltiazem ointment with Lidocaine in a double blind randomized controlled trialTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To assess the complaints of perianal irritation/itching during the course of 6-week therapy. 2)Any adverse events due to systemic absorption of topical drugs. Timepoint: 3 weeks and 6 weeks | — |
Countries
India
Contacts
Public ContactDr Piyush Ranjan
AIIMS,Delhi
Outcome results
None listed