Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
None listed
Sponsors
CCRAS ministry of Ayush
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age:18-35 years with PCOS as defined by Rotterdam revised criteria 2003 (2 out of 3 symptoms if present) i. Anovulation or Oligo-ovulation ii. Hyperandrogenism- a) Clinical (acne, hirsutism, acanthosis nigricans). b) Biochemical: total testosterone >70ng/dl iii. 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 the reproductive tract like T.B, Carcinoma, and Congenital deformities. 3. Participants suffering from Hypertension, Diabetes Mellitus, Hepatic/Renal disease, Cushingââ?¬•s syndrome, and 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 drugs recently to be excluded unless a washout period of 1 month. 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 has 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 the past 6 months. 11. Any other condition that the Principal Investigator thinks may jeopardize the study. 12. Virechana Ayogsya (Ch. Si. Chap.2/12-13)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure ââ?¬Â¢ Attainment of normal menstrual cycle length (21-35days) or Ovulation (Clinically or USG). ââ?¬Â¢ Changes in hirsutism as per modified Ferriman-Gallwey (FG) Score. (Annexure I) Timepoint: Primary Outcome Measure ââ?¬Â¢ Attainment of normal menstrual cycle length (21-35days) or Ovulation (Clinically or USG). ââ?¬Â¢ Changes in hirsutism as per modified Ferriman-Gallwey (FG) Score. (Annexure I) | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Changes in Acne score (Annexure II) and acanthosis nigricans. [Time frame: at base line, 140th day & 200th Day.] ââ?¬Â¢ Changes in abdominal girth/waist circumference & BMI. ââ?¬Â¢ To assess the clinical safety of coded Ayurvedic formulation Ayush-SSM. Timepoint: ââ?¬Â¢ Changes in Acne score (Annexure II) and acanthosis nigricans. [Time frame: at base line, 140th day & 200th Day.] ââ?¬Â¢ Changes in abdominal girth/waist circumference & BMI. [Time frame: at base line, 200th day.] ââ?¬Â¢ To assess the clinical safety of coded Ayurvedic formulation Ayush-SSM. [Time frame: at base line and 200th day.] | — |
Countries
India
Contacts
Public ContactDr Sarada Ota
CARI CCRAS Ministry of Ayush
Outcome results
None listed