Efficacy of Ksharasutra prepared through automated machine and manual process in fistula-in-ano: A study protocol for a double-blind, randomized controlled trial

A. Rai, B. Yadav, H. Panigrahi, R. Singhal, B. Chandrasekhararao, Rakesh Rana, Narayanam Srikanth
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Abstract

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
自动机器和手工工艺制备Ksharasutra治疗瘘管的疗效:一项双盲、随机对照试验的研究方案
背景:即使在当今时代,Ksharasutra的制造过程仍然主要是手工的。它必然导致小规模生产和这种有效治疗的可得性受到限制。CCRAS开发了一种自动化机器的原型,用于大规模生产《经》。目的:本临床研究将探讨自动器械制备经的安全性和有效性,并将其与手工制备经的疗效进行比较。材料和方法:本研究是一项双盲、随机对照、平行组试验,在新德里的中央阿育吠陀研究所进行。总共有100名参与者将被纳入这项研究。年龄在18-60岁的任何性别的被诊断为肛门瘘管的个体,并抱怨肛周分泌物、疼痛、压痛、瘙痒和硬化,将被纳入试验。被招募的参与者将由试验组的自动机器准备的经书和对照组的手动准备的经书进行管理。每周更换经,直到瘘道完全切断。结局指标包括生活质量的改变(通过SF-36问卷评估)、瘘道单位切割时间、参与者瘘道完全愈合的比例和不良事件的发生率。讨论:传统的肛管手术治疗与显著的复发率和肛门失禁受损的高风险相关。与传统治疗相比,按摩疗法简单、经济、术后护理少、并发症少、复发率低。然而,由于手工制备的小规模生产,制造Ksharasutra所涉及的技术不均匀,等等限制了这种疗法的可用性和质量。认识到穴拉陀疗法的益处以及在此过程中经验丰富的外科医生的可用性,可以在提高这种手术辅助技术的可及性方面发挥重要作用。试验注册:CTRI/2021/12/038414,日期为2021年12月3日
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