Efficacy and safety of three Ayurveda decoctions for Polycystic Ovary Syndrome: a study protocol for a randomized, single-blind, three-arm, clinical trial

Running title: Ayurveda decoctions for PCOS: a study protocol

Abstract

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine abnormalities in women of reproductive age. Due to fear of side effects and adverse effects of allopathic medicines, some patients prefer to take Ayurveda treatments for PCOS. Therefore, the aim of this research is to design a randomized, single-blind, three-arm, comparative clinical trial to detect the efficacy and safety of three Ayurveda decoctions (decoction of Nigellasativa, decoction of Sesamumindicumand decoction of Nigellasativa and Sesamumindicum). Rotterdam's (2003) diagnostic criteria will be used to diagnose PCOS. The selection of participants will be done according to the inclusion and exclusion criteria and allocated randomly into the three arms.  Participants of Arm I, Arm II, and Arm III will receive an oral drug for twelve weeks and will be followed up for three months after the drug administration. Each patient will undergo hematological and biochemical investigations (FBS, FBC, ESR, AST/ALT, and serum creatinine/GFR) and a urine full report before and after the interventions, which are done primarily for safety assessment. Trans Abdominal Sonography or Trans-Vaginal Sonography will be carried out before, after the treatment, and during the follow-up period as primary outcome measures. Symptom severity and their impact on quality of life will be assessed at the beginning and end of the treatment by PCOS symptoms and the Health-Related Quality of life Questionnaire. Body constituent (Prakriti) identifying each at the screening with the help of a questionnaire which is already validated. The relation in-between constituent and PCOS will be evaluated at the beginning and the effect of therapy according to the body constituent will be evaluated at the end of the study. For primary and secondary outcome measures, the mean values at baseline and at the end of the study and the mean differences will be compared between the three arms using ANOVA (analysis of variance) or the non-parametric Kruskal–Wallis test, depending on the normality of the data. Intention-to-treat analysis will be performed for all efficacy outcomes and safety outcomes. At the end of this clinical research, it will be able to provide evidence-based scientific data on the classical Ayurveda treatment.