Health Condition 1: N911- Secondary amenorrhea
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.DIAGNOSED WITH PCOS as defined by Rotterdam revised criteria 2003 (2 out of 3 symptoms if present) a.Anovulation or Oligo-ovulation b.Hyperandrogenism- Clinical (acne, hirsutism, acanthosis nigricans). Or Biochemical: total testosterone >70ng/dl c.Polycystic ovary on USG ( >12 Follicles in an ovary each of 2-9mm in size) ovarian volume >10 cm3 2.Willing and able to participate in the study
Exclusion criteria
Exclusion criteria: 1. Participants who want to conceive during this period or planning for pregnancy will be excluded. 2. Organic lesions of reproductive tract like T.B, Carcinoma and Congenital deformities. 3. Participants suffering from Hypertension, Diabetes Mellitus, Hepatic/Renal disease, Cushingâ??s syndrome, Cardiac diseases. 4. A current or previous use of OC pills, Glucocorticoids, anti-androgens, Ovulation induction agents, anti-diabetic, anti-obesity drug or other hormonal drug recently to be excluded unless a washout period of 3 months. 5. Pelvic inflammatory disease or Cervicitis Evidence of malignancy or cervical intra-epithelial neoplasia or cervical carcinoma. 6. History of untreated sexually transmitted disease or known to be HIV positive. 7. Pregnant / Lactating women. 8. Participant who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9. H/o hypersensitivity to the trial drug or any of its ingredients. 10. Currently participating in any other clinical trial or participated in past 6 months. 11. Any other condition which the Principal Investigator thinks may jeopardize the study. Virechana Ayogy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Resumption of spontaneous regular cycles in patients with oligo/amenorrhoea Timepoint: at base line & end of the treatment 110th day (90th day of samana )and at the end of follow up period 140th day(120th day of Samana) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction in Ovarian volume(Bilateral) evaluated by USG 2.Normal values for Serum FSH,LH & LH: FSH Timepoint: at base line & end of the treatment 110th day (90th day of samana )and at the end of follow up period 140th day(120th day of Samana)] | — |
Countries
India
Contacts
Public ContactDr Sarada Ota
Central Council for Research in Ayurvedic Sciences-New Delhi
Outcome results
None listed