None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women between 20 to 40 years of age. 2.Presence of ovarian volume greater than 10 cubic centimeters in at least one ovary, assessed by transvaginal ultrasound on Day 5 to Day 10 of the menstrual cycle. 3.Presence of micro polycystic ovaries with 12 or more follicles per ovary in at least one ovary, assessed by transvaginal ultrasound. 4.No hormonal treatment received within 6 months prior to enrolment in the study. 5.Luteinizing hormone to follicle stimulating hormone ratio greater than 2.5. 6.Absence of any adrenal or other endocrine disorder. 7.Women willing to undergo transvaginal ultrasound for ovarian assessment. 8.Women able to understand the study requirements and comply with all procedures required by the study protocol. 9.Ability and willingness to provide written informed consent and comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1.Women with known allergies to Shatavari, oats, raisins, almonds, cocoa, or honey. 2.Women diagnosed with congenital adrenal hyperplasia, androgen secreting tumours, or Cushing syndrome. 3.Women with a history of infertility, hypothyroidism, twin pregnancy, or higher order births. 4.Women with any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illness, or the presence of any current psychiatric disorder. 5.Women who have used any investigational drug within three months prior to enrolment in the study. 6.Women who are unable to comply with the study procedures or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 16 in the ovarian volume and follicle count assessed on transvaginal ultrasound scanTimepoint: Baseline and Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 16 in the total and domain-specific scores of the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ) scale.Timepoint: Screening and Enrollment, Week 4, Week 8, Week 12, Week 16;Mean change from baseline to week 16 in the perceived stress scale (PSS-10) scoreTimepoint: Screening and Enrollment, Week 4, Week 8, Week 12, Week 16;Mean change from baseline to week 16 in the scores for mental health assessed using the Depression Anxiety Stress Scale (DASS-21).Timepoint: Screening and Enrollment, Week 4, Week 8, Week 12, Week 16;Mean change in Global Acne Grading System (GAGS) from baseline to week 16Timepoint: Screening and Enrollment, Week 4, Week 8, Week 12, Week 16;Mean change in levels of shedding range of the hair via hair pull test from baseline to week 16Timepoint: Screening and Enrollment, Week 4, Week 8, Week 12, Week 16;Mean change in Ferriman-Gallwey scores from baseline to week 16Timepoint: Screening and Enrollment, Week 4, Week 8, Week 12, Week 16;Mean change from baseline to week 16 in the body mass index (BMI).Timepoint: Screening and Enrollment, Baseline, Week 4, Week 8, Week 12, Week 16;Mean change in Bedtime cortisol levels from baseline to Week 16Timepoint: Baseline and Week 16;Mean change in Cortisol Awakening response (CAR) from baseline to Week 16.Timepoint: Baseline and Week 16;Mean change in laboratory parameters (HbA1C) from baseline to week 16Timepoint: Screening and Enrollment; and Week 16;Mean change in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline to week 16Timepoint: Screening and Enrollment; and Week 16;Mean change in serum insulin by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from baseline to week 16Timepoint: Screening and Enrollment; and Week 16;Mean change in hepatic (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline to week 16Timepoint: Screening and Enrollmen | — |
Countries
India
Contacts
Public ContactDr Hemant Mandlik
Sukhakarta Hospital
Outcome results
None listed