clinical trial on PCOS through Ayurveda and Yoga treatment

Phase 3

• Conditions: Health Condition 1: N970- Female infertility associated withanovulationHealth Condition 2: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2022/04/042089
• Lead Sponsor: Banaras Hindu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients of female infertility who satisfied the Rotterdam criterion (2/3 of the features) for PCOS

1-Oligo/amenorrhea: Absence of menstruation for 45 days or more and/or less than eight menses per year.

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

3-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

1-Patients who use of oral contraceptives/hormone treatment/insulin-sensitizing agents within previous six weeks.

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

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

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

5-The patients suffering from diabetes mellitus, hypertension, thyroid disorders, hyper prolactinemia, congenital adrenal hyperplasia, other gynaecological disorders, and renal failure

6-Patients with evidence of malignancy

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

8-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.

9-Symptomatic patient with clinical evidence of Heart failure.

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

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

12-Any other condition which the Principal Investigator thinks may jeopardize the study

Study Duration : 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the change in ovarian morphology in terms of ovulation, rate and judged by transvaginal USG of ovaries on 9th to 11th day of cycleTimepoint: 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
1.To asses changes in anthropometric measurements (body weight, body mass index [BMI], chest circumference, waist circumference, hip circumference, mid-arm circumference, and waistâ??hip ratio) at the end of 12 weeks. <br/ ><br>2.To Hospital Anxiety and Depression Scale [HADS] at end of every 12 weeks. <br/ ><br>3.To of menstrual frequency at the end of every 4 weeks. <br/ ><br>Timepoint: 6 months