Health Condition 1: null- Patients suffering from Poly Cystic Ovarian Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Attainment of Normal menstrual pattern (21-35 days) 2. Obesity -Waist Hip Ratio, and BMI 3. Regression of Ovarian Cysts- as evidenced by USG and possible Ovulation study. 4. Safety. Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Metabolic parameters- FBS: F.Insulin. 2. Changes in Hirsutism(Modified Ferriman-Gallwey (FG) Score) 3. Changes in Acne Score (Pillsbury, et al,1956) 4. Changes in Hormone level- S. FSH, S.LH, and S. Insulin. 5. Improvement in QoL as per PCOSQ. Timepoint: 3 months | — |
Countries
India
Contacts
IPGT and RA