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Journal of Research in Ayurvedic Sciences 2022 April - June ; 6 (2) :87-92
Efficacy of Ksharasutra prepared through automated machine and manual process in fistula-in-ano: A study protocol for a double-blind, randomized controlled trial

BACKGROUND: The manufacturing process of Ksharasutra is still predominantly manual, even in the current era. It inherently leads to small-scale production and restricted availability of this effective treatment. CCRAS has developed a prototype of an automated machine to manufacture the Ksharasutra on a large scale. OBJECTIVE: This clinical study will investigate the safety and efficacy of the Ksharasutra prepared through the automated machine and compare its efficacy with the manually prepared Ksharasutra. MATERIALS AND METHODS: This study is a double-blind, randomized controlled, parallel-group trial being conducted at the Central Ayurveda Research Institute, New Delhi. A total of 100 participants will be enrolled in the study. Individuals of any sex aged 18–60 years and diagnosed with fistula-in-ano complaining of perianal discharge, pain, tenderness, itching, and induration will be enrolled in the trial. The enrolled participants will be managed by the automated machine-prepared Ksharasutra in the trial group and the manually prepared Ksharasutra in the control group. The Ksharasutra will be changed every week till the fistula tract is completely cut off. The outcome measures include the change in the quality of life (assessed through the SF-36 questionnaire), unit cutting time of the fistula tract, the proportion of participants having complete healing of the fistula tract, and the incidence of adverse events. DISCUSSION: The conventional surgical treatment of fistula-in-ano is associated with a significant recurrence rate and a high risk of impaired anal continence. Compared with conventional treatment, Ksharasutra therapy is simple, cost-effective, and associated with minor post-operative care, minimal complications, and a low recurrence rate. However, small-scale manufacturing due to manual preparation, non-uniformity of techniques involved in the manufacturing of Ksharasutra, and so on limits the availability and quality of this therapy. Awareness regarding the benefits of Ksharasutra therapy and availability of surgeons experienced in this procedure can play a significant role in improving the accessibility of this para-surgical technique. TRIAL REGISTRATION: CTRI/2021/12/038414, dated 3 Dec. 2021 Keywords: ?Bhagandara, chemical seton, fistula-in-ano, Ksharasutra, para-surgical procedure

DHARA ID: D060671

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