Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
None listed
Sponsors
MotherSoul Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult female participants, 18 to 40 years of age (both inclusive) both married or unmarried. 2. Participants with USG confirmed diagnosis of polycystic ovarian disease. 3. Participants with LH/FSH ratio greater than or equal to 2:1. 4. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation. 2. Participants with uterine fibroid, polyp, adenomyosis, ovarian mass or tumour. 3. Participants with a known history of tubercular endometriosis. 4. Participants with known history of congenital adrenal hyperplasia, congenital absence or deformities of uterus and ovaries. 5. Participants having congenital anomalies in the female genital tract. 6. Participants with a current use of hormonal contraceptives or any drugs that may have an influence on the outcome of the study. 7. Participants who have been using fertility drugs within 6 months of the study. 8. Participants diagnosed with premature ovarian failure and dysfunctional uterine bleed. 9. Participants with a history of malignancy or any ongoing malignancy. 10. Participants with known history of uncontrolled hypertension or uncontrolled Type 2 Diabetes Mellitus. 11. Participants with any thyroid abnormalities or dysfunctions at screening. 12. Participants with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts); or cerebrovascular accident. 13. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic, endocrine, neurological, rheumatological and renal diseases necessitating medical care. 14. Participants using phytoherbal supplements, herbal extracts, nutraceuticals or ayurvedic supplements 3 months prior to screening. 15. Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant. 16. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 17. Participants who are pregnant or lactating or planning to become pregnant during the study period. Participants who are not ready to use acceptable contraceptive methods during the course of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) ratio from baseline to end of study.Timepoint: 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ovarian volume and appearance assessed with pelvic (abdominal) sonography from baseline to end of study.Timepoint: 90 Days;Mean change in total testosterone from baseline to end of study.Timepoint: 90 Days;Mean change in severity of pain during menstruation assessed using Visual Analog Scale from baseline to end of study.Timepoint: 90 Days;Mean change in bleeding using the Menstruation Assessment Chart from baseline to end of study.Timepoint: 90 Days;Mean change in menstrual cycle intervals (in days) assessed with last menstrual period (LMP) from baseline to end of study.Timepoint: 90 Days;Mean change in mood swings using the Hospital Anxiety and Depression Scale (HADS) assessment from baseline to end of study.Timepoint: 90 Days;Mean change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) assessment from baseline to end of study.Timepoint: 90 Days;Mean change in hirsutism using the modified Ferriman Gallwey Score assessment from baseline to end of study.Timepoint: 90 Days;Mean change in BMI and waist circumference from baseline to end of study.Timepoint: 90 Dyas;Safety Endpoint: The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.Timepoint: 90 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed