A Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective, Clinical Study to Evaluate the Efficacy and Safety Of regime of “DHATHREE†in subjects with polycystic ovary syndrome (PCOS).

This is a Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective, Clinical Study to Evaluate the Efficacy and Safety Of regime of “DHATHREE†in subjects with polycystic ovary syndrome (PCOS). Subjects fulfilling the inclusion and exclusion criteria will be enrolled in the study. Enrolled subjects will be under treatment for 12 weeks.The study will include 2 periods for a total of up to 13 weeks: Subjects who meet all the eligibility criteria, based on medical history and clinical examination will be recruited in this study. The duration of a subject’s participation will be approximately 3 months’ in the study. Screening Visit: Visit 1(Day-28 to Day 0) ·Screening assessments may be performed for up to 28 days prior to randomization. Randomization will occur once all screening assessments are complete, and subject’s eligibility for participation is confirmed. ·The following assessments will be done prior to randomization: ·Obtaining Written informed consent (prior to any study-specific procedure) ·Collection of demographic, medical and medication history and personal history ·Physical examination complete general examination, measurements of weight, height, BMI, waist and hip circumference measurement. ·Notes: ØWaist circumference will be measured midway between lower rib margin and the iliac crest in the mid-axillary line at the end of normal expiration. ØHip circumference will be measured with the measuring tap at the highest prominence of the buttock sand parallel to the floor. ·Menstrual history: Regularity of menses: cycle to cycle variation over ·12 months, frequency of menses, heaviness of menstrual flow, and duration of menstrual flow ·Vital signs (pulse rate, respiratory rate, blood pressure, body temperature) ·Assessment of eligibility criteria ·Laboratory assessments: hematology, fasting blood glucose (FBG), PPBG, IR, lipid profile (TC, HDL, LDL, TG), Sex hormone binding globulin (SHBG), Hormone profile* (Luteinizing hormone, FSH, Estradiol,Progesterone), Serum Testosterone level,17-Hydroxy progesterone and urinalysis ·*Hormone profile: ·On Day 02 and on Day 03 of menstrual cycle: FSH, LH and Estradiol ·On Day 21 of menstrual cycle -Progesterone ·Serum Pregnancy test ·Pelvic ultrasound will be performed at screening for determining the eligibility of the Subject, if a recent report is not available(within 3 months) ·Once above assessments are completed and subject’s eligibility is confirmed, following procedures will be performed: Visit-02: Randomization (Day 01): Treatment allocation either Dhatree or Placebo ·Allocation and dispensing of study treatment, and subject diaries ·Prior and concomitant medications recording ·Adverse event recording and reporting, as applicable ·Urine Pregnancy Test The subject will be followed up at Visit 3: (Day 15 ± 2) (Telephonic) Visit 4: Interim (Day 30 ± 3) Visit 5: Follow up 3 (Day 45 ± 2) (Telephonic) Visit 6: End of Study (EOS)assessment (Day 60 ± 3)   The following assessments will be performed at each of these clinic study visits: oEvaluation of menstrual frequency & improvement in frequency of menstruation– ·Physical examination, complete general examination, measurements of weight, and hip and waist circumferences and BMI. ·Vital signs measurements (pulse rate, respiratory rate, blood pressure, body temperature) ·Laboratory assessments: ØAt screening and Week 8: Hematology, lipid profile (TC, HDL, LDL, TG), Hormone profile* (Luteinizing hormone, FSH, Estradiol, Progesterone), PPBG, IR, Sex hormone binding globulin (SHBG), Serum Testosterone level,17-Hydroxy progesterone and urinalysis ØUrine Pregnancy Test. ØFasting Blood Glucose level-at all site visits ·Dispensing of study medication at Visit-02 and 04 ·Reviewing Subject diaries ·Prior and Concomitant medications recording ·Adverse event recording and reporting, as applicable ·Final accountability of study treatment/tablets and retrieval at week 8. ·Return of subject dairy at week 8. ·Subjects who test positive for pregnancy any time during the study will be discontinued from the study, and will be followed up by the investigator as per regulatory requirement.