Clinical assessment of the efficacy of Ayurvedic management in PCOS Ã¢â?¬â?? a randomized open label control trial

CCRAS ministry of Ayush0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•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.

•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, CushingÃ¢â?¬•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)

发起方

CCRAS ministry of Ayush