Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
None listed
Sponsors
Sandipani Healthcare Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Females aged 18 to 45 years, fulfilling at least 2 of following 3 criteria diagnosis of PCOS. 2.History of irregular menstrual cycles e.g., cycle length varying by more than 7 days, or cycles less than 21 days or more than 35 days for at least the past 3 to 6 months, potentially attributed to hormonal imbalance. 3.BMI between 18.5 and 38 kg per m2 inclusive 4.LH and FSH ratio more than 1 will be enrolled in the study. 5.Willing and able to provide written informed consent and comply with study procedures. 6.No use of anti-diabetic or anti-obesity medications for at least 3 months prior to screening. 7.Willing to come for follow up visits for evaluation 8.No significant medical or surgical diseases at the time of screening.
Exclusion criteria
Exclusion criteria: 1.Pregnancy, planning pregnancy during the study period or lactation. 2.Use of hormonal contraceptives or hormone replacement therapy within the last 3 months. 3.Diagnosed with severe endocrine disorders e.g., uncontrolled thyroid disease, Cushing syndrome or significant organic pelvic pathology e.g., large fibroids, endometriosis requiring immediate intervention. 4.Known allergy or hypersensitivity to any ingredient in She Care Juice. 5.Use of other treatments pharmacological or herbal known to affect menstrual cycles or hormonal balance within the last month. 6.Significant systemic, immunological, cardiovascular, hepatic, renal or gastrointestinal disorders. 7.Participation in another clinical trial within the last 90 days. 8.Any condition that in the opinion of the investigator would jeopardize the safety of the participant or the integrity of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the proportion of participants achieving regular menstrual cycles 21-35 days or documented ovulation. 2.Mean change in modified Ferriman Gallwey FG Score. 3.Mean change in serum LH, FSH, LH and FSH ratio, and Total Testosterone levels.Timepoint: 1.Screening, Day 30, Day 60, Day 90. 2.Screening, Day 90. 3.Screening, Day 60, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in the IGA score for acne. 2.Mean change in Weight and BMI. 3.Mean change in fasting insulin, HOMA-IR, HbA1C, lipid profile. 4.To assess the change in quality-of-life score (e.g., using PCOS-Q).Timepoint: 1.Screening, Day 30, Day 60, Day 90. 2.Screening, Day 30, Day 60, Day 90. 3.Screening,Day 60, Day 90. 4.Screening,Day 30,Day 60, Day 90. | — |
Countries
India
Contacts
Public ContactMr Manoj Karwa
Sandipani Healthcare Pvt Ltd.
Outcome results
None listed