Effect of Ayurvedic tratment medicines on Garbhashaya Granti

Phase 2

• Conditions: Health Condition 1: null- Patients suffering from Poly Cystic Ovarian Disease

• Registration Number: CTRI/2012/12/003183
• Lead Sponsor: IPGT and RA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Rotterdam revised criteria 2004 two out of three criteria if present

1 Hyper androgenism Clinical or Biochemical

2 Oligomenorrhoea Amenorrhoea Anovulation and menstrual irregularities.

3 PCO features on USG more than 10 follicles in a ovary or one cyst of more than 10 mm in size

4 Others 1 Age Adolescent and Reproductive Age group 12 to 40years

2 History of Poly Cystic Ovarian Syndrome in mother or female sibling with clinical manifestations.

5 Ability and willingness to provide signed informed consent.

Exclusion Criteria

ï??Pelvic /Systemic diseases (like Endometriosis, Hydrosalpinx, Fibroid uterus) causing Oligomenorrhoea and Anovulation.

ï??Organic lesions of reproductive tract like T.B, Carcinoma and congenital deformities

ï??Patients suffering from the following clinical conditions will be excluded

A)Adrenal Hyperplasia

B)Androgen secreting neoplasm

C)Thyroid Dysfunction

D)Cushingâ??s syndrome

E)Cardiac diseases

F)Hyperprolactinaemia

G)Diabetes Mellitus

H)Hypertension

I)Chronic Hepatic /Renal Diseases.

J)Current or previous (within last 6 months) use of OC Pills, Gluco-cordticoids,

Anti-androgens, Ovulation Induction agents, anti diabetic, anti-obesity drugs, or other hormonal drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Attainment of Normal menstrual pattern (21-35 days) <br/ ><br>2.Obesity -Waist Hip Ratio, and BMI <br/ ><br>3.Regression of Ovarian Cysts- as evidenced by USG and possible Ovulation study. <br/ ><br>4.Safety. <br/ ><br>Timepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
1.Changes in Metabolic parameters- FBS: F.Insulin. <br/ ><br>2.Changes in Hirsutism(Modified Ferriman-Gallwey (FG) Score) <br/ ><br>3.Changes in Acne Score (Pillsbury, et al,1956) <br/ ><br>4.Changes in Hormone level- S. FSH, S.LH, and S. Insulin. <br/ ><br>5.Improvement in QoL as per PCOSQ. <br/ ><br>Timepoint: 3 months