Currently accepted at: JMIR Research Protocols
Date Submitted: Dec 6, 2025
Date Accepted: Mar 30, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/88548
The final accepted version (not copyedited yet) is in this tab.
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
ABSTRACT
Background:
Background:
Parikarthika refers to the condition in which the subject 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. The management can be divided into conservative, operative and adjuvant therapy. 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 procedure is 60% and that with the Ayurveda protocol, the expected recurrence rate is 30%.
Objective:
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:
Methods:
A prospective, randomized controlled interventional open labelled study has been designed to enrol a total of 90 participants from OPD of NARIP Cheruthuruthy, Kerala. They will be screened for Fissure in ano based on physical examination. The participants satisfying inclusion and exclusion criteria will be randomly allocated to either trial group (n=45) or control group (n=45). In the trial group participants will be managed with Avipattikar churna, Triphala guggulu internally and Jatyadi taila anal infiltration as well as Lepana along with sitz bath in Triphala kashaya externally. Diltiazam gel will be given for external application in 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:
Results:
This project was funded in June 2024.The institutional ethics committees at National Ayurveda Research Institute for Panchakarma (03/01/2024/NARIP/Tech/786) approved this study. The first participant was enrolled in April 2025; 9 participants were enrolled as of May 2025. The results of the trial groups will be compared with that of the control group. Pre and post treatment assessments will be conducted at comparable moments in both groups, with baseline assessment. The subsequent assessments will be on 14th, 28th ,56th ,84th and 112th day. The results will be subjected to univariate and multivariate analysis using appropriate statistical methods.
Conclusions:
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). Clinical Trial: Trial registration number: CTRI/2024/09/073793
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