Homoeopathic intervention in polycystic ovarian syndrome

Phase 2

Conditions: Health Condition 1: null- Polycystic ovarian syndrome

Registration Number: CTRI/2013/09/003983

Lead Sponsor: Central Council of Research in Homoeopathy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 60

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 2Â±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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Establishment of regular menstrual cycle along with either ultrasonological improvement of PCO or improvement in hirsutism/ acne.Timepoint: Baseline and 6 months.

Secondary Outcome Measures

Name	Time	Method
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.