Efficacy of Nitya Virechana with Naracha Choorna, Sahacharadi Taila Matra Basthi and Shatapushpadi Yoga orally in the management of Artavadushti W.S.R. to non-obese polycystic ovarian syndrome: A Single Arm Open Labelled Clinical Trial

Introduction:

Polycystic Ovarian Syndrome [PCOS] is the most common endocrine and metabolic disorder in a woman of reproductive age. It is a multifactorial and polygenic condition. It is heterogenous by nature and can be defined by a combination of sign and symptoms of androgen excess and ovarian dysfunction in the absence of other specific diagnosis. It is a complex syndrome showing the clinical features of an endocrine/metabolic disorder, including hyperinsulinemia and hyperandrogenism. Clinically it is characterized by menstrual abnormalities, hirsutism, acne, obesity, insulin resistance and baldness.

There are two phenotypes of PCOS, obese and non-obese with different biochemical hormonal and metabolic profiles. Although a majority of cases with PCOS are obese/overweight, a small but significant proportion of patients present with normal body mass index or low BMI (≤25 kg/m2) that makes diagnosis work up and therapeutic approach more difficult. These cases of PCOS are termed as non-obese PCOS. Causative factor for non-obese PCOS are stress factor, nutritional factor and genetic factor. Women with non-obese PCOS may struggle with irregular periods, anxiety, uncontrolled blood sugar, fertility problems, and other caused by elevated androgen (testosterone) levels such as excess facial hairs and acne.

 Rationale for selection of the topic:

PCOS is a global health issue for women’s health in current scenario due to changes in life style, habits and mental stress from menarche to menopause. Overweight women with PCOS may be diagnosed with their absent or irregular 3 cycles when they are still in high school. Comparatively, non-obese PCOS women may not diagnosed until they struggle to conceive.

There are only few research works available on non-obese PCOS.There is no fixed protocol or interventional drug or procedure to approach non-obese PCOS patients.

Drugs for the selected study are Naracha Choorna, Sahacharadi Taila and Shatapushpadi Yoga. Acharya Charaka has said that repeated elimination of Doshas should be done by Mrudu Virechana drug in weak patients who have more Doshas. Naracha Choorna helps in Vatanulomana. Sahacharadi Taila is Vatashamaka and Yonidoshahara due to Ushna-Tikshna properties. Acharyas have mentioned Rasayana and Doshanusara Chikitsa in Artvadushti .So, Shatapushpadi Yoga that contains Shatapushpa,Shatavari and Brahmi has been selected for the same.

 Aim: - To evaluate  the efficacy of Nitya Virechana with Naracha Choorna, Sahacharadi  Taila Matrabasti and Shatapushpadi   Yoga orally in the management of non-obese PCOS.

Objectives:

•       To assess the efficacy of Nitya Virechana with Naracha choorna, Sahacharadi Taila Matra Basthi and   Shatapushpadi  Yoga  orally  on ovarian morphology.

•        To assess the efficacy of Nitya Virechana withNaracha Choorna orally, Sahacharadi Taila Matra Basthi and    Shatapushpadi  Yoga  orally on menstrual abnormality.

 Materials and Methods: Primarily, subjects will be selected on the basis of symptoms of PCOS. Further, if subjects fulfill the inclusion criteria and suspected pathologies if any, are ruled out, then appropriate written informed consent will be taken from the subjects to participate in the study. The cases will be registered for the clinical trial from O.P.D and I.P.D of Department of Prasuti Tantra Evam Stree Roga or such cases referred from other departments of ITRA Jamnagar irrespective of Caste and religion . Patients will be screened and examined with the help of Rotterdam criteria of non-obese (BMI ≤25 kg/m2) PCOS based on clinical and USG parameters. Further assessment will be done according to specially designed proforma.Sample size of the study will be 20, assigned in a single group.Naracha choorna for Nitya virechana orally ,Sahacharadi taila Matra Basti in two consecutive menstrual cycle and Shatapushpadi Yoga orally will be administerd for 2 months.Followup period will be 1 month.

Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. The important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Side Effects: This drug has no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.