Health Condition 1: null- Polycystic ovarian syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: i.Female aged 18 to 36 years ii. Oligomenorrhea (Intermenstrual period of more than 35 days for 3 consecutive cycles)/amenorrhea for more than 3 months (two years after menarche) iii.Ultrasound findings of Polycystic ovaries The PCO should have at least one of the following: either 12 or more follicles measuring 2±9 mm in diameter or increased ovarian volume ( >10 cm3). If there is evidence of a dominant follicle ( >10 mm) or a corpus luteum, the scan should be repeated during the next cycle. Only one ovary fitting this definition or a single occurrence of one of the above criteria is sufficient to define the PCO. iv.Clinical evidence of hirsuitism (Ferriman score 8 and above)16 and/ or acne (acne global severity scale score 1 and above) v.Body mass index (BMI) 23 and above vi.Participants willing to adopt healthy diet and to take regular exercise (at least 30 minutes of exercise at least 5 days a week). vii.Written Informed consent from the patient
Exclusion criteria
Exclusion criteria: i. History of diabetes mellitus ii. History of cushing disease iii. History of hyperprolactinemia iv. Untreated hypo or hyperthyroidism v. History of adrenal hyperplasia and adrenal tumor vi. Ovarian tumor vii. Hyperthecosis viii. Significant renal impairment ix. History of intake of drugs aldactone/ metformin or history of OCP use or intake of drugs known to interfere with carbohydrate metabolism prior 4 weeks before enrolment x. Pregnancy, breast feeding xi. Cases with other systemic diseases like cardiovascular, endocrinal diseases or Systemic infections or on other treatment therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Establishment of regular menstrual cycle along with either ultrasonological improvement of PCO or improvement in hirsutism/ acne.Timepoint: Baseline and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To compare the changes in total and individual domain scores of PCOSQ in verum and placebo groups at monthly interval for 6 months.Timepoint: Every month for 6 months.;â?¢ To compare the changes in ultrasound reports of polycystic ovaries at entry and 6 months in verum and placebo groups.Timepoint: Baseline and 6 months. | — |
Countries
India
Contacts
Central Council of Research in Homoeopathy