CTRI/2025/10/096231
Recruiting
Not Applicable
A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
MotherSoul Private Limited3 sites in 1 country66 target enrollmentStarted: November 10, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- MotherSoul Private Limited
- Enrollment
- 66
- Locations
- 3
- Primary Endpoint
- Mean change in Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) ratio from baseline to end of study.
Overview
Brief Summary
“A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).”
Primary Objective:
To evaluate the efficacy of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
Secondary Objective:
To evaluate the safety of Shatavari (Asparagus racemosus) Capsules for management of Hormonal Balance and Menstrual Health in women with Polycystic Ovarian Syndrome (PCOS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Adult female participants, 18 to 40 years of age (both inclusive) both married or unmarried.
- •Participants with USG confirmed diagnosis of polycystic ovarian disease.
- •Participants with LH/FSH ratio greater than or equal to 2:
- •Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion Criteria
- •Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation.
- •Participants with uterine fibroid, polyp, adenomyosis, ovarian mass or tumour.
- •Participants with a known history of tubercular endometriosis.
- •Participants with known history of congenital adrenal hyperplasia, congenital absence or deformities of uterus and ovaries.
- •Participants having congenital anomalies in the female genital tract.
- •Participants with a current use of hormonal contraceptives or any drugs that may have an influence on the outcome of the study.
- •Participants who have been using fertility drugs within 6 months of the study.
- •Participants diagnosed with premature ovarian failure and dysfunctional uterine bleed.
- •Participants with a history of malignancy or any ongoing malignancy.
- •Participants with known history of uncontrolled hypertension or uncontrolled Type 2 Diabetes Mellitus.
Outcomes
Primary Outcomes
Mean change in Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) ratio from baseline to end of study.
Time Frame: 90 Days
Secondary Outcomes
- Change in ovarian volume and appearance assessed with pelvic (abdominal) sonography from baseline to end of study.(90 Days)
- Mean change in total testosterone from baseline to end of study.(90 Days)
- Mean change in severity of pain during menstruation assessed using Visual Analog Scale from baseline to end of study.(90 Days)
- Mean change in bleeding using the Menstruation Assessment Chart from baseline to end of study.(90 Days)
- Mean change in menstrual cycle intervals (in days) assessed with last menstrual period (LMP) from baseline to end of study.(90 Days)
- Mean change in mood swings using the Hospital Anxiety and Depression Scale (HADS) assessment from baseline to end of study.(90 Days)
- Mean change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) assessment from baseline to end of study.(90 Days)
- Mean change in hirsutism using the modified Ferriman – Gallwey Score assessment from baseline to end of study.(90 Days)
- Mean change in BMI and waist circumference from baseline to end of study.(90 Dyas)
- Safety Endpoint:(The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.)
Investigators
Dr Alaka C Godbole
Akshaya Surgical and Maternity Home
Study Sites (3)
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