A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Beni-Suef University
- Enrollment
- 180
- Locations
- 1
Study Overview
Brief Summary
This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.
Detailed Description
This is a prospective randomized controlled parallel-group clinical trial evaluating the effects of alpha-lipoic acid combined with myo-inositol, with or without metformin, in women with polycystic ovary syndrome (PCOS).
A total of 180 patients will be randomized into three groups:
Myo-inositol with folic acid Myo-inositol + alpha-lipoic acid Myo-inositol + alpha-lipoic acid + metformin
The study duration is 6 months. Outcomes include menstrual regularity, ovulation rate, hormonal parameters, metabolic markers, and clinical signs of hyperandrogenism.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 21 to 40 years
- •Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
- •Not currently pregnant or lactating
- •No hormonal therapy within the last 3 months
- •Willing and able to provide informed consent
Exclusion Criteria
- •- History of diabetes mellitus, hypertension, or thyroid disorders
- •History of cardiovascular, renal, or hepatic disease
- •Use of hormonal contraceptives or insulin sensitizers within the last 3 months
- •Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)
- •Non-Egyptian ethnicity
Investigators
Ahmed Abdelkader
Lecturer Assistant
Beni-Suef University