Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Regime of DHATREE: 2 Herbal capsules one hour after breakfast once a day and 1 Multivitamin (MVM) Sachet after lunch once a day, for 60 days
Control Intervention1: Placebo regime of DHA
Sponsors
Gangwal Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult female subjects 18 and 40 (both inclusive) years of age. 2.Subject diagnosed of polycystic ovary syndrome (PCOS), according to Rotterdam Criteria, if she has 2 of the following 3 manifestations: a) Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of = 8). b) Disturbed ovulatory function with chronic oligomenorrhea (cycles of > 35 days, less than nine cycles per year), or amenorrhea (cycle length > 12 weeks) after negative screening pregnancy test. c)Polycystic ovary as shown by PELVIC ultrasonography. 3.Subjects with established insulin resistance 4.Subject having BMI = 34.9 kg/m2. 5.Subject is willing and able to take oral medications. 6.Subject is willing to continue with regular follow-up as required for the study 7.Subject willing to observe barrier contraception (oral contraceptives or any other hormonal medications not to be consumed) during the study period.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.Subject with previous medical history or currently having any of the following conditions- Cushing syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia; or any other hormonal dysfunction. 3.Subject with history or current status of diabetes mellitus, uncontrolled hypertension, symptomatic cardiovascular diseases. 4.Subject with any acute or chronic infections at the time of screening. 5.Subject with history of malignancies. 6.Subject with known history of gynecological surgery. 7.Subject having impaired renal or liver function at the time of screening. 8.Subject who is currently on a medically-assisted weight loss program with medication or surgical procedures. 9.Subject currently having laparoscopic ovarian diathermy. 10.Subject who is willing to or currently undergoing in vitro fertilization (IVF), or considering participation in any artificial reproduction techniques (ART) program. 11.Subject who has received or is currently receiving following medication within past 3months of screening: clomiphene citrate, insulin sensitizers like Metformin and thiazolidinediones, aromatase inhibitors like anastrozole, letrozole, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, hormonal contraceptives, antiandrogens like spironolactone, cyproterone acetate (CPA), and flutamide, anti-obesity drugs, or any traditional or herbal medicines. 12.Known history or current use of alcohol, smoker or tobacco user, or subject with unstable mental illness. 13.Subject is participating or has participated in any other clinical trial within last 30 days prior to screening. 14.In the opinion of the investigator, the subject is not eligible to participate or may not comply the study procedures. 15.Subject having contraindication or known allergy to any of the study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of subjects with improvement in menstrual cycle disturbance at 08 weeks of treatment in DHATREE arm vs. Placebo arm (Note: Improvement in menstrual cycle disturbance should be considered in accordance with FIGO recommendations).Timepoint: Day 0 to Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in serum testosterone levels after 08 weeks of treatment 2. Changes in systolic and diastolic blood pressure after 08 weeks of treatment 3. Changes Hip-Waist ratio after 08 weeks of treatment 4. Changes in BMI after 08 weeks of treatment 5. Changes in lipid levels (TC, TG, LDL and HDL) after 08 weeks of treatment 6. Changes in Estradiol/Progesterone/LH/FSH/SHBG after 08 weeks of treatment 7. Percentage of subjects with improvement in Insulin resistance at 08 weeks of treatment in DHATREE arm vs. Placebo armTimepoint: Day 0 to Day 60 | — |
Countries
India
Contacts
Public ContactNeha Gondhale
Alchemy Clinical Research Services
Outcome results
None listed