Clinical assessment of the efficacy of Ayurvedic management in PCOS: Study protocol for a randomized open-label standard control trial

Abstract

Abstract INTRODUCTION: Polycystic ovary syndrome (PCOS) is a heterogeneous disorder, typically characterized by anovulation, hormonal imbalances, obesity, infertility, and associated features, with a significant impact on the physiological and psychological wellbeing of females belonging to the reproductive age group. Due to the multifactorial etiology, treatment is often personalized with specific targets, and monotherapy is rarely used. In the present study, the efficacy of an Ayurveda regimen, comprising the Ayush-SSM tablet (a coded Ayurvedic formulation) administered after Virechana therapy (purgation), is being explored against conventional standard care. MATERIALS AND METHODS: This study is an open-label, randomized, controlled clinical trial consisting of 180 participants diagnosed with PCOS. The participants in the trial group will receive Ayurvedic treatment consisting of Virechana therapy followed by administration of Ayush-SSM (500 mg), two tablets twice a day for 6 months. The participants in the control group will receive metformin tablet 500 mg once a day in the first week, 500 mg twice a day in the second week, 500 mg thrice a day in the third week, and 850 mg twice a day from the fourth week till 6 months. The primary outcome is the proportion of study participants who attain normal menstrual cycle length (21–35 days) or ovulation and change in hirsutism as per the modified Ferriman–Gallwey (FG) Score. The secondary outcomes are change in acne score and acanthosis nigricans; change in abdominal girth, waist circumference, and BMI; and clinical safety of the trial interventions. CONCLUSION: The findings of the study could potentially demonstrate that the Ayurveda regimen, including Virechana therapy followed by administration of the Ayush-SSM tablet, may be as effective as conventional standard care. Trial registration: Clinical Trial Registry of India (CTRI/2022/09/045478, dated August 4, 2022).