Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: CL22209: 100 mg per day, One capsule a day after breakfast for 84 days
Intervention2: CL22205: 200 mg per day, One capsule a day after breakfast for 84 days
Control Intervention1: Place
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy females aged between 20 and 35 years with a Body Mass Index (BMI) of approximately 22 to 29 kg/m2. 2. Diagnosed with PCOS as assessed by gynaecologist according to the Rotterdam scale- Should have the following criteria: i)Oligo/anovulation (Oligo-amenorrhea- cycles > 35 days apart or ii)Polycystic ovaries morphology on transvaginal ultrasound using 8MHz frequency transducer (ovarian volume: greater than or equal to 10 cm3 and/or greater than or equal to 20 follicles per ovary). Note: USG & lab tests will be performed on 3-5 days of menstrual cycle. 3. Subject understands the study procedures and provides signed informed consent to participate in the study. 4. Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study. 5. Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion criteria
Exclusion criteria: 1. History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs on a daily basis for any conditions. 2. Fasting blood glucose level >125 mg/dl. 3. Patients who had any hormonal therapy, metformin or any other herbal products in the past 3 months. 4. Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushings syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months, taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months (except the usual drugs of the patients). 5. Active gall bladder disease, gynaecological or breast surgery in the last 6 months. 6. Subjects underwent hysterectomy. 7. History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years. 8. Smokers or tobacco users. 9. Pregnant and lactating mothers. 10. History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products. 11. History of positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis. 12. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 13. Participated in a clinical study with an investigational drug or biologic within the last 30 days. 14. Any condition that in opinion of the Investigator, does not justify the subjects’ participation in the study. 15. Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure. 16. Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases. 17. Subjects with a high blood pressure at screening (systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100mmHg). 18. High alcohol intake ( >2 standard drinks per day), or recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Ovarian volume by UltrasoundTimepoint: Visit 1 (Screening), Day 42 & Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Anthropometric measurements (body weight, waist & hip circumferences).Timepoint: Day 1, Day 42 & Day 84;Change from baseline to the end of the study period in Follicle-stimulating hormone (FSH), Luteinizing Hormone (LH), testosterone, & sex hormone binding globulin (SHBG)Timepoint: Visit 1 (Screening) & Day 84;Change from baseline to the end of the study period in Homeostatic Model Assessment for Insulin Resistance - HOMA-IR (Fasting Insulin & fasting glucose)Timepoint: Visit 1 (Screening), Day 42 & Day 84;Change from baseline to the end of the study period in Mean ovarian cyst size (mm)Timepoint: Visit 1 (Screening), Day 42 & Day 84;Change from baseline to the end of the study period in Number of ovarian folliclesTimepoint: Visit 1 (Screening), Day 42 & Day 84;Change from baseline to the end of the study period in Regularity in menstrual cyclesTimepoint: Day 1, Day 42 & Day 84;Change from baseline to the end of the study period in Scores of ‘Global Acne Grading system’ for acne.Timepoint: Day 1, Day 42 & Day 84;Change from baseline to the end of the study period in Scores of modified Ferrimen & Gallwey questionnaire for HirsutismTimepoint: Day 1, Day 42 & Day 84 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed