Efficacy of an Ayurvedic Management Protocol on the Rate of Recurrence, Healing and Safety in Parikarthika (Fissure in Ano): Protocol for a Randomized Controlled Trial.

Background: Parikarthika refers to the condition in which the individual experiences a sensation of pain as if the Guda is being cut around with scissors. This condition can be correlated to the fissure in ano. It has been described as an acute superficial break in the continuity of the anoderm, usually in the posterior midline of the anal canal. The incidence of anal fissures is around 1 in 350 adults. Management can be divided into conservative, operative, and adjuvant therapies. The main challenge in the management of fissure in ano is the increased rate of recurrence. Here comes the importance of an alternative therapy which can reduce the recurrence. The recurrence rate of fissure in ano by nonsurgical procedures is 60%, and with the Ayurveda protocol, the expected recurrence rate is 30%. Objective: This study aims to evaluate the efficacy of an Ayurvedic management protocol on the rate of recurrence, healing, and safety in Parikarthika (fissure in ano). Methods: A prospective, randomized controlled interventional open-labeled study has been designed to enroll a total of 90 participants from the OPD (Outpatient Department) of National Ayurveda Research Institute for Panchakarma (NARIP), Cheruthuruthy, Kerala. They will be screened for fissure in ano based on physical examination. Participants satisfying the inclusion and exclusion criteria will be randomly allocated to either the trial group (n=45) or the control group (n=45). In the trial group, participants will be managed with Avipattikar churna and Triphala guggulu internally and Jatyadi taila anal infiltration, as well as Lepana along with sitz bath in Triphala kashaya externally. Diltiazem gel will be given for external application in the control group along with Triphala kashaya sitz bath and Triphala churna internally. The intervention is given for a period of 28 days, and participants are evaluated on 14th, 28th, 56th, 84th, and 112thday. The assessment parameters include recurrence rate, treatment efficacy, safety, comparative tolerability, and change in health-related quality of life. Results: This project was funded in June 2024, and the study duration is 36 months. The first participant was enrolled in April 2025; 9 participants were enrolled as of May 2025. The data analysis will be completed by October 2027 and the results are anticipated to be published by December 2027. Conclusions: The study is expected to demonstrate the efficacy of an Ayurvedic management protocol on the rate of recurrence, healing, and safety in Parikarthika (fissure in ano).