Efficacy of Yashtimadhu Ghrita anal infiltration versus topical diltiazem in chronic anal fissure: Protocol for an open-label randomized controlled trial

BACKGROUND: Chronic anal fissure is a common and painful condition characterized by a longitudinal tear in the distal anal canal, often associated with bleeding and severe pain during defecation. In Ayurvedic literature, a similar clinical presentation is described under Parikartika . Yashtimadhu Ghrita , a classical Ayurvedic formulation, is traditionally indicated for its wound-healing, anti-inflammatory, and mucosal protective properties. Topical diltiazem is widely used in contemporary management due to its ability to reduce internal anal sphincter spasm; however, variability in healing outcomes and recurrence remains a clinical concern. In this context, the present study is designed to compare the efficacy and safety of Yashtimadhu Ghrita anal infiltration with topical diltiazem in the management of chronic anal fissure. MATERIALS AND METHODS: This study is an open-label, randomized controlled trial enrolling 100 participants aged 18–60 years with chronic anal fissure of more than 6 weeks’ duration. Following written informed consent, eligible participants will be randomly allocated in a 1:1 ratio to either the intervention or control group. In the intervention group (Group A), 10 mL of Yashtimadhu Ghrita , warmed to body temperature, will be administered via anal infiltration twice daily (morning and evening) following a sitz bath with Sphatika Bhasma at a concentration of 2 g per 10 L of water. In the control group (Group B), participants will receive 2% topical diltiazem gel, applied 1.5–2 cm into the anal canal twice daily (morning and evening) after a sitz bath with Sphatika Bhasma . The intervention period in both groups will be 30 days. All participants will receive Triphala Churna 10 g orally at bedtime for 30 days; the dose would be individualized based on tolerance and clinical response. Participants will be followed up for a total duration of 180 days to assess study outcomes. The trial is currently in the recruitment and follow-up phase. OUTCOME MEASURES: The primary outcome is the proportion of participants achieving complete healing of chronic anal fissure after 30 days. Secondary outcomes include healing rates at 1 and 2 weeks, reduction in defecation pain (visual analogue scale) on days 8, 15, 22, and 30, time to cessation of bleeding, recurrence at days 60, 90, and 180, and any adverse events within 30 days. CONCLUSION: This study aims to evaluate the efficacy and safety of Yashtimadhu Ghrita in the management of chronic anal fissure. The findings are expected to provide evidence regarding its potential role in the therapeutic management of this condition. CLINICAL TRIAL REGISTRATION: CTRI/2023/05/052302 on May 04, 2023.