Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Evakind Tablet. Dosage One tablet twice a day: Dosage One tablet twice a day. Each film coated tablet contains
Extracts:
Ashoka (Saraca asoca) Stem Bark 60 mg
Methi (Trigonella foenum g
Sponsors
IMS BHU
Eligibility
Inclusion criteria
Inclusion criteria: Rotterdam Criteria Two of the three following criteria are diagnostic of the condition, assuming other causes have been excluded: • Polycystic Ovaries • Oligo-ovulation or anovulation. Number of menstrual cycles in last 1 year ( • Clinical and/or biochemical signs of Hyperandrogenism (HA) Signs of clinical HA: • Sexual hair growth graded by modified Ferriman-Gallwey3 (mFG) Score >=6-8 • Global Acne Grading System4 • Androgenic alopecia Biochemical Signs of HA: • Total Testosterone • Luteinizing Hormone (LH) • Follicle Stimulating Hormone (FSH) Investigational Polycystic ovarian Morphology confirmation by Ultrasonography • Presence of at least 12 follicles measuring 2 to 9 mm in the whole ovary. • increased ovarian volume (greater than 10 cm3)
Exclusion criteria
Exclusion criteria: Age >40 years or patients with menopausal levels of FSH ( > 20mIU/mL) Hyperprolactinemia (Serum prolactin >30 ng/mL) Patients with known 21-hydroxyase deficiency5 (Serum 17-hydroxyprogesterone Patients with uncorrected Thyroid disease ( defined as TSH 5.5 mIU/mL) Patients on oral contraceptives, depo progestins, or hormonal implants, GnRH agonists and antagonists, IUCD (intra uterine contraceptive device) or using barrier contraceptives. Organic lesion of the reproductive tract if any: 1.Benign growth 2.Malignant growth 3.Extensive cervical erosion 4.Cervical polyps 5.Endometriosis History of spontaneous abortion in last 3 months. History of any of the following systemic disorders: 1.Diabetes mellitus type 1 2.Coronary artery disease 3.Hypertension 4.Renal disease 5.Hepatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoints 1.Clinical features of PCOS at the end of study 2.Length and days of menstrual cycle 3.Quantity of menstrual flow 4.Hirsutism 5.Acne 6.Androgenic alopecia 7.Anthropometric parameters at the end of study 8.BMI 9.WHR 10.Ultra-sonography for the morphology of ovary at the end of study 11. Level of hormones (Testosterone, LH, FSH) at the end of studyTimepoint: Visit 1, Day 0, baseline (Recruitment) Visit 2, Day 30±2 days (Assessment visit) Visit 3, Day 60±2 days (Assessment visit) Visit 4, Day 90±2 days (Assessment visit) Visit 5, Day 120±2 days (Assessment visit) Visit 6, Day 150±2 days (Assessment visit) Visit 7, Day 180±2 days (Assessment visit) Visit 8, Day 365±7days (Follow-up visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Restoration of spontaneous fertility in married women who wanted to be pregnant.Timepoint: Visit 8, Day 365±7days (Follow-up visit) | — |
Countries
India
Contacts
Public ContactDrAshutosh Gautam
IMS BHU
Outcome results
None listed