Health Condition 1: null- Female Subjects with Polycystic Ovarian Syndrome
Conditions
Interventions
Intervention1: Evecare forte tablets: 1 Tablet twice daily for a period of 3 months.
Control Intervention1: Metformin: 1 Tablet twice daily for a period of 3 months.
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Females aged Between 18 years to 45 Years. 2.Women with signs and symptoms of PCOS like irregular menstrual cycles, weight gain, biochemical/clinical hyperandrogenemia, hirsutism etc. 3.History of PCOS with 4.PCOS confirmed by Clinical and or biochemical and or ultrasonographical findings. 5.Willingness to sign consent for study including participation with collection of blood specimens.
Exclusion criteria
Exclusion criteria: 1.Patients who is not using oral contraceptive pills, hormonal treatment or IUCDs. 2.Patients who had no systemic illness like hypertension, renal disease, tuberculosis, hepatic disease, diabetes, coagulation disorder, etc. 3.Patients with organic lesion of the reproductive tract especially any benign or malignant growth, extensive cervical erosion, cervical polyps, endometriosis. 4.Patients with severe Hepatic or cardiac or mental illness. 5.Patients unwilling to provide informed consent or abide by the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Regularisation of the frequency and variability of menstrual cycle. 3.Improvement in hormonal profile 4.Improvement in metabolic profile like Blood glucose and insulin levels, cholesterol, triglycerides, HDL and LDL. 5.To normalise change in ovary on ultrasonography. Timepoint: End of Month 1, End of Month 2 and End of month 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse events during the study periodTimepoint: Month 1 Month 2 Month 3;overall compliance to the drug treatmentTimepoint: Month 1 Month 2 Month 3 | — |
Countries
India
Contacts
Public ContactDr Padmanabha
Rudrappa Health Care & Diagnostics
Outcome results
None listed