Evaluate the efficacy and safety of Probiotic on the clinical and biological parameters of reproductive-aged PCOS women.
- Conditions
- Health Condition 1: K588- Other irritable bowel syndrome
- Registration Number
- CTRI/2024/03/064022
- Lead Sponsor
- Vidya Herbs Pvt LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria (the presence of antral follicle count (AFC) of 12 or more and or an ovarian volume greater than 10 mL).
2.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF).
3.Willingness and capability to complete all the study procedures.
•During the pregnancy and lactation period.
•Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
•Use of antibiotics within 3 months.
•Symptoms of any infection at screening.
•Immunodeficient or use of immunosuppressive drugs.
•Use of products containing prebiotics or probiotics within the last 3 months.
•Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
•Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the MSQ symptom score from baseline to Day 90 (end of study)Timepoint: i.Screening and Enrollment visit <br/ ><br>ii. Visit 01(Day 01) Baseline <br/ ><br>iii. Visit 02 (Day 14 ± 3 days) Assessment Visit <br/ ><br>iv. Visit 03 (Day 28 ± 3 days) Assessment visit <br/ ><br>v. Visit 04 Day 45 (Interim visit) <br/ ><br>vi. Visit 05 (Day 56 ± 3 days) Assessment visit <br/ ><br>vii. Visit 06 (Day 70 ± 3 days) Assessment visit <br/ ><br>viii. (Day 90): End of Treatment Visit
- Secondary Outcome Measures
Name Time Method •Change in the MSQ symptom score from baseline to Day 45 (end of study) <br/ ><br>•Change in the Modified Ferriman and Gallwey score from baseline to Day 45 and Day 90 (end of study) <br/ ><br>•Change in the Visual assessment scale score for acne from baseline to Day 45 and Day 90 (end of study) <br/ ><br>•Change in the Fasting Blood sugar level from baseline to Day 90 (end of study) <br/ ><br>•Change in the HbA1c level from baseline to Day 90 (end of study) <br/ ><br>•Change in the FSH from baseline to Day 90 (end of study) <br/ ><br>•Change in the LH from baseline to Day 90 (end of study) <br/ ><br>•Change in the Serum estradiol levels from baseline to Day 90 (end of study) <br/ ><br>Timepoint: Day 45 and day 90