Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Ayuvita Forte Capsules: contains Mucuna pruriens, Saraca indica, Symplocos paniculat, Glycyrrhiza glabra, Sida cordifoli, Withania somnifera, Asparagus racemosus, Asparagus adscendens,
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects diagnosed with PCOS by ppresence of two of the of the three Rotterdam criteria: Oligomenorrhea, anovulation; Hyperandrogenism; and the observation of polycystic ovaries by USG of the Lower Abdomen and Pelvis. 2.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion (as diagnosed by USG lower abdomen and pelvis). 2. Subjects having clinical and/or biochemical signs of severe hyperandronism 3. Subjects having systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, Hirsutism, Addisonââ?¬•s disease and/or Cushing disease. 4. Subjects with one year of history of child birth 5. History of genitor-urinary surgery, and/or other major medical or surgical diseases; which can affect or related with study outcomes. 6. Nursing, pregnant or lactating women. 7. Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit. 8. Use of any other investigational drug within 1 month prior to screening visit. 9. Patient having known hypersensitivity to any ingredient of the study drug. 10. Pregnant and Lactating females. 11. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of subjects achieving ovulation. 2. Number of subjects achieving regular menstruation Timepoint: day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Testosterone. 2.Change in polycystic ovary as observed in the USG. 3.Changes LH, FSH, Progesterone, Estrogen 4.Changes in HbA1c, Blood sugar F and PP and Serum Insulin 5.Global assessment for overall change by subject and investigator at the end of study treatment. 6.Tolerability of study drug 7.Adverse events 8.Changes in laboratory parameters Timepoint: day -7, day 0, day 30, day 60, day 90, day 120, day 150 and day 180 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed