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Clinical evaluation of Ayurvedic regimen in the management of Polycystic Ovarian Syndrome

Phase 3
Conditions
Health Condition 1: N911- Secondary amenorrhea
Registration Number
CTRI/2023/06/054016
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.DIAGNOSED WITH PCOS as defined by Rotterdam revised criteria 2003 (2 out of 3 symptoms if present)

a.Anovulation or Oligo-ovulation

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

c.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 reproductive tract like T.B, Carcinoma and Congenital deformities.

3. Participants suffering from Hypertension, Diabetes Mellitus, Hepatic/Renal disease, Cushingâ??s syndrome, 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 drug recently to be excluded unless a washout period of 3 months.

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 have 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 past 6 months.

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

Virechana Ayogy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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