Clinical trial of Validated Yoga Protocol on Polycystic ovarian Syndrome (PCOS)

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients who satisfied the Rotterdam criterion (2/3 of the features) for PCOS will be included in the study. The following were the

definitions of the three features. Oligo/amenorrhea: Absence of menstruation for 45 days or more and/or less than eight menses per

year.

Clinical hyperandrogenism, Modified Ferriman and

Gallway (mFG) score of 6 or higher. Biochemical hyperandrogenism, serum LH and FSH ratio more than 2:1.

Poly cystic ovaries: Presence of >10 cysts, 2-8 mm in diameter, usually combined with increased ovarian volume of >10 cm3, and an echo-dense stroma in pelvic ultrasound scan

Exclusion Criteria

Patients who use of oral contraceptives/hormone

treatment/insulin-sensitizing agents within

previous six weeks.

Patients who have addiction of alcohol, smoking and any prior experience of yoga.

Patients who have Hyperprolactinemia, thyroid abnormalities and non-classic adrenal hyperplasia, and those who did not consent for the study.

Patients who have Primary ammenorheoa, Premature ovarian failure, absent ovary and uterus.

The patients suffering from diabetes mellitus, hypertension, thyroid disorders, hyperprolactinemia, congenital adrenal hyperplasia, other gynaecological disorders, and renal failure.

Patients with evidence of malignancy.

Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)

Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

Symptomatic patient with clinical evidence of Heart failure.

Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

Patients who have completed participation in any other clinical trial during the past six (06) months.

Any other condition which the doctor thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see the efficacy of validated Yoga Protocol on <br/ ><br>menstrual characteristics in pcos patientsTimepoint: 6 months with follow up of every 4th week

Secondary Outcome Measures

Name	Time	Method
To assess the effect of validated Yoga module on Agni assessment scale, Hospital Anxiety & Depression Scale Perceived stress scale & quality of life in PCOS women at the end of 8th week 16th week 24th week. <br/ ><br>To assess the effect of validated Yoga module on anthropometric measurements (body weight, body mass index [BMI], chest circumference, waist circumference, hip circumference, mid-arm circumference, & waist–hip ratio) at the end of 8th week 16th week 24th week. <br/ ><br>To assess the effect of validated Yoga module on ovarian morphology as judged by ultrasound monitoring of the ovaries at 1st & 24th week <br/ ><br>To assess the effect of validated Yoga module on FSH, LH, TSH, PRL & Testosterone at 1st week and 24th week <br/ ><br>To assess the effect of validated Yoga module on CBC LFT Lipid Profile and Blood glucose level at 1st and 24th weekTimepoint: 6 Months