Efficacy of Ayurveda treatment in obese Poly Cystic Ovarian Syndrome

Phase 2

Not yet recruiting

Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

Registration Number: CTRI/2023/10/058816

Lead Sponsor: Institute of Teaching and Research in Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)20 to 40 years of age

2)Both married and unmarried patients

3)Patients with BMI 30.0 to 34.9 (Obesity class I) & 35.0 to 39.9 (Obesity class II) as per WHO’s Classification of Obesity

4)Diagnosed cases as per Rotterdam Diagnostic criteria of PCOS.

5)Patient who provide voluntary agreement for participation in the trial and provide informed consent prior to treatment.

Exclusion Criteria

1) Young females who had their menarche in less than 3 years

2) Lactating mothers

3) Patient not willing to participate in this study

4) Patients who are unfit for the interventional procedure like Snehana, Swedana, and Virechana Karma

5) Patients having Endocrinopathies.

6) Known case of Premature ovarian failure

7) Patients having Organic lesions of reproductive tract

8) Patients having systemic disorders like severe cardiac, pulmonary, hepatic, or renal diseases, central nervous system disorder, Hypertension (Systolic BP greater than or equal to 160 and Diastolic greater than or equal to 100mmhg)

9) Patients with medications currently taking or took within 3 months like high dose exogenous androgens, hormonal treatment for PCOS, a current or previous use of OC pills, glucocorticoids, anti- androgens, ovulation induction agents, anti-diabetic, anti-obesity drug or other hormonal drugs

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Changes in the volume of ovary as per USG <br/ ><br>2)Changes in the antral follicle count (AFC) as per USG <br/ ><br>3)Changes in the size of follicles as per USG <br/ ><br>4)Changes in the distribution of follicles (Peripheral cystic pattern or Generalized cystic pattern) as per USG 5)Changes in the stromal echogenicity as per USGTimepoint: on 0th day (before treatment), On 24th day (DT), on 80th day (after treatment)

Secondary Outcome Measures

Name	Time	Method
1)Changes in the inflammatory biomarkers after the intervention <br/ ><br>2)Relief in subjective symptoms & changes in the objective parameters after the intervention <br/ ><br>3)Effect of intervention on insulin resistance in obese PCOS patients <br/ ><br>4)Changes in Homeostatic model assessment-insulin resistance (HOMA-IR) index <br/ ><br>5)Improvement on quality of life in PCOS patientsTimepoint: on 0th day (before treatment), On 24th day (DT), on 80th day (after treatment)