Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients
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
Beni-Suef University
180 participants
Mar 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- \- 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
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Interventions
Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.
Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.
Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.
Metformin administered orally starting at 500 mg once daily and titrated over two weeks to a maximum dose of 1500 mg/day (500 mg three times daily), taken after meals for 6 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07630779