Health Condition 1: null- Polycystic Ovary Syndrome and or Subfertilty in Women
Conditions
Interventions
Intervention1: Multiple Micro-nutrients Supplementation: One Formula A Tablet + one Formula B Tablet together after main meal twice a day for 4 months
Ingredients Formula A: N-acetyl L-Cysteine, Eleme
Sponsors
Meyer Organics Pvt Ltd Thane
Eligibility
Inclusion criteria
Inclusion criteria: Young women of age between 18 to 38 yrs with PCOS [Presence of any two of the following parameters: (Roterdam criteria 2003) Oligomenorrhea and/or anovulation. Subjects with Hyperandrogenism. (clinical and/or biochemical) (Ferriman-Gallwey score >8; biological (LH/FSH ratio >2] OR Subfertile females Sexually active and male partner with potential of produce a child Polycystic ovaries with exclusion of other etiologies. Women with normal uterine cavity Subjects with Impaired Glucose Tolerance or Insulin Resistance. Normal physical activity confirmed with physical and clinical examination, and routine laboratory tests, including AST, ALT, hematology routine urinalysis and measurement of oral temperature and vital signs.
Exclusion criteria
Exclusion criteria: Pregnant or lactating women. Subjects with presence of infertility factors other than anovulation Subjects with pelvic organic pathologies, presence of other pathologies such as non-classical congenital adrenal hyperplacia, cushingâ??s syndrome and androgen secreting tumors, Subjects with thyroid dysfunction, hyprolactenemia, androgen secreting neoplacia. Women requiring, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and antiobesity drugs, or other hormonal drugs. Subjects taking vitamins & micronutrient supplementation at the time of screening. Subjects with any neoplastic, metabolic, and cardiovascular disorder or other concurrent medical illness (i.e. type 1 or type 2 diabetes, renal disease, and malabsorptive disorders, acute and chronic inflammations) confirmed based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis. Subjects with known history of hypersensitivity to the study drugs. Alcoholic consumers and smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in overall status of PCOS syndromes or infertilityTimepoint: Day 30 60 90 and 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in different parameters defining the status of PCOS or Infertility like Hormonal levels insulin resistance weight and safety of the therapyTimepoint: Baseline Day 30 60 90 120 | — |
Countries
India
Contacts
Public ContactOnkar Rathod
Outcome results
None listed