Efficacy and safety of Murivenna anal infiltration compared to Diltiazem topical application in chronic anal fissure: Study protocol for a prospective randomized open-label clinical trial (Preprint)

Abstract

Background: Anal fissure is a common proctologic condition that causes significant pain and anguish to the patient, significantly impacting the quality of life and wellbeing. There is various treatment options for anal fissures, ranging from pharmacological agents that reduce anal sphincter tone to surgical interventions for cases resistant to medical management. Ayurveda treatments have shown potential for the therapeutic management of anal fissures. This clinical study is aimed to analyse the efficacy and safety of Murivenna anal infiltration compared to Diltiazem topical application in chronic anal fissure. Methods/design: This is an open-labeled randomized, controlled parallel group clinical trial with a sample size of 66 participants to be randomized and allocated in a 1:1 ratio to two groups. The intervention group will be treated with Murivenna anal infiltration, and the control group will be treated with Diltiazem topical application for period of four weeks. The primary outcome is the proportion of participants who underwent complete healing after four weeks of treatment. The secondary outcome measures will be the proportion of participants demonstrating complete healing after 7 days and 14 days of treatment, respectively, change in pain at or after defecation, cessation of bleeding, and incidence of any recurrence during the study period. Incidence of any adverse events will also be recorded during the trial period. Discussion: High recurrence rates, adverse effects, incomplete healing, and the negative impact on patient’s daily activities and quality of life underscore the need for alternative therapeutic options. Ayurveda offers potential for more sustainable relief with fewer adverse effects. Murivenna oil is time-tested medicated oil effectively used by Ayurvedic physicians for various ulcers of traumatic and pathological origin. This study may provide scientific evidence on the efficacy and safety of Murivenna anal infiltration for chronic anal fissure. TRIAL REGISTRATION: CTRI/2023/09/057330 [Registered on: 06/09/2023]