To see the efficacy of Ayurvedic management of PCOS

Phase 2

• Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2022/09/045478
• Lead Sponsor: CCRAS ministry of Ayush

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Age:18-35 years with PCOS as defined by Rotterdam revised criteria 2003 (2 out of 3 symptoms if present)

i. Anovulation or Oligo-ovulation

ii. Hyperandrogenism-

a) Clinical (acne, hirsutism, acanthosis nigricans). b) Biochemical: total testosterone >70ng/dl

iii. Polycystic ovary on USG ( >12 Follicles in an ovary each of 2-9mm in size) ovarian volume >10 cm3

2. Willing and able to participate in the study.

Exclusion Criteria

1.Participants who want to conceive during this period or planning for pregnancy will be excluded.

2.Organic lesions of the reproductive tract like T.B, Carcinoma, and Congenital deformities.

3. Participants suffering from Hypertension, Diabetes Mellitus, Hepatic/Renal disease, Cushingââ?¬•s syndrome, and Cardiac diseases.

4.A current or previous use of OC pills, Glucocorticoids, anti-androgens, Ovulation induction agents, anti-diabetic, anti-obesity drug, or other hormonal drugs recently to be excluded unless a washout period of 1 month.

5.Pelvic inflammatory disease or Cervicitis Evidence of malignancy or cervical intra-epithelial neoplasia or cervical carcinoma.

6.History of untreated sexually transmitted disease or known to be HIV positive.

7.Pregnant / Lactating women.

8.Participant who has a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke, or Severe Arrhythmia in the last 6 months.

9.H/o hypersensitivity to the trial drug or any of its ingredients.

10.Currently participating in any other clinical trial or participated in the past 6 months.

11.Any other condition that the Principal Investigator thinks may jeopardize the study.

12.Virechana Ayogsya (Ch. Si. Chap.2/12-13)

Study & Design

• Study Type: Interventional
• Study Design: Not specified