Health Condition 1: K588- Other irritable bowel syndrome
Conditions
Interventions
Intervention1: Probiotic bacillus subtilis strain.: Dose:Take one capsules or as directed, best taken prior to a meal.
Frequency:One Capsule or as directed Route of Administration: Oral Total Duratio
Sponsors
Vidya Herbs Pvt LTD
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: ?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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the MSQ symptom score from baseline to Day 90 (end of study)Timepoint: i.Screening and Enrollment visit ii. Visit 01(Day 01) Baseline iii. Visit 02 (Day 14 ? 3 days) Assessment Visit iv. Visit 03 (Day 28 ? 3 days) Assessment visit v. Visit 04 Day 45 (Interim visit) vi. Visit 05 (Day 56 ? 3 days) Assessment visit vii. Visit 06 (Day 70 ? 3 days) Assessment visit viii. (Day 90): End of Treatment Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Change in the MSQ symptom score from baseline to Day 45 (end of study) ?Change in the Modified Ferriman and Gallwey score from baseline to Day 45 and Day 90 (end of study) ?Change in the Visual assessment scale score for acne from baseline to Day 45 and Day 90 (end of study) ?Change in the Fasting Blood sugar level from baseline to Day 90 (end of study) ?Change in the HbA1c level from baseline to Day 90 (end of study) ?Change in the FSH from baseline to Day 90 (end of study) ?Change in the LH from baseline to Day 90 (end of study) ?Change in the Serum estradiol levels from baseline to Day 90 (end of study) Timepoint: Day 45 and day 90 | — |
Countries
India
Contacts
Public ContactDr Suman G
Rajalakshmi Hospital
Outcome results
None listed