Comparative Effectiveness of Panchamrut Parpati and Placebo in Management of Grahani W.S.R. to Irritable Bowel Syndrome - Study Protocol for a Single Blind, Randomized Controlled Trial

Abstract: Background: Ayurveda has described several treatment modalities regarding the treatment of Grahani Roga including the usage of herbs and formulations, yoga and lifestyle modifications. On the other hand, systematic data regarding their efficacy relative to placebo are not currently available. The purpose of this study is to compare the efficacy of the Ayurvedic formulation Panchamrut Parpati with a placebo, which contains an inert component called starch, in the treatment of Grahani Roga patients. Methods and design: In a prospective, single- centered, randomized controlled trial,60 patients, between 19 and 60 years, diagnosed with Grahani Roga, presenting with cardinal features of Grahani Roga as presented in Ayurvedic texts, two groups will be randomly assigned. In Group one, the patients will receive Panchamrut Parpati and in Group two, patients will receive Placebo filled with starch. Guidelines regarding Pathya-apathya will be given to both the groups. The course of treatment will last for 28 days for both groups. Outcomes will be evaluated on 14th&28th (During treatment) & 56th day (post-treatment). Result:The primary result will be assessed by checking the grading of the cardinal symptoms of Grahani Roga mentioned in Ayurvedic texts. Secondary outcome will check for improvement in laboratory investigations and quality of life of the patient. Conclusion: This trial compares the efficacy of Panchamrut Parpati with Placebo in the patients of Grahani roga. Panchamrut Parpati is envisioned to improve the symptoms of Grahani Roga, thus proving to be effective in management of patients of Grahani Roga. Trial registration: CTRI/2023/07/055048