Efficacy of herbal supplements (CL22209 and CL22205) on polycystic ovary syndrome (PCOS)
- Conditions
- Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
- Registration Number
- CTRI/2023/11/059457
- Lead Sponsor
- CLS Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 <8 cycles per year) in the past one year and FSH 1–10 U/L, with normal E2.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to the end of the study period in Ovarian volume by UltrasoundTimepoint: Visit 1 (Screening), Day 42 & Day 84
- Secondary Outcome Measures
Name Time Method