Treatment for Poly Cystic Ovarian Syndrome

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2019/03/018084
• Lead Sponsor: Dr S Anitha

Brief Summary

A clinical trail is done to evaluate the efficacy of the Ayurvedic formulation Kalyanaka Kshara in the management of P.C.O.S Induced Infertility and to validate scientifically the observations that would significantly change the LH FSH ratio, Testosterone, Prolactin levels and also signs and symptoms of Polycystic Ovaries. Klayanaka Kshara is a unique herbal formula which has the reference in Astanga Hridaya  Chikitsa Stana - a classical text. 50 patients orally 250 mg twice daily for 90 days and to compare the observation with other group in which Rajah Pravartini Vati 250 mg along with Varunadi Kashaya 20 ml administered in 50 patients  for 90 days with the observation on 0 - 30 - 60 - 90 days and further follow up for secondary outcome i.e., achievement of fertility, the study would be conducted in India, to complete in 3 years and the trail time being 18 months. Primary outcome measures will be relief in signs and symptoms (subjective parameters), subsiding the P.C.O.S symptoms and achieve ovulatory cycles, fertility

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-02-28
• Study Start: 2019-12-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Married infertility patients with P.C.O.D. (Rotterdam criteria) Irregular menses scanty menses due to Anovulatory cycle Anovulation and Oligo amennorohoea Elevated LH (LH:FSH ratio >3) Clinical or biochemical evidence of Hyperandrogenism Polycystic ovary (more than 10 follicles in a ovary or one cyst more than 10 mm) Willing to give pre-informed consent for the study.

Exclusion Criteria

• Unmarried patients with P.C.O.D. Age below 20 years and above 40 years Patients associated with other gynaecological disorders Patients suffering with any chronic diseases Women having the history of primary amenorrhea Patients with Tubercular endometritis Patients with congenital anomalies in female genital tract Patients with chronic liver disease, renal disorder, etc.
• Patients with metabolic and other Endocrinal disorders like Diabetes Mellitus Patients with Hypothyroidism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in signs and symptoms and significant improvement of objective parameters tests to 50% baseline	Every month | 30th day, 60th day, 90th day

Secondary Outcome Measures

Name	Time	Method
Improvement in objective parameters	Achievement of Ovulation and Fertility

Trial Locations

Locations (1)

AL GOVT AYURVEDIC HOSPITAL; 🇮🇳 Krishna, ANDHRA PRADESH, India

AL GOVT AYURVEDIC HOSPITAL

🇮🇳Krishna, ANDHRA PRADESH, India

DR S ANITHA

Principal investigator

9640868554

dranitha2005@yahoo.com