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.
