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Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients

NCT07630779 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-05

No results posted yet for this study

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.

Conditions

  • Poly Cystic Ovary Syndrome

Interventions

DRUG

Myo-inositol

Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.

DIETARY_SUPPLEMENT

Folic Acid

Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.

DRUG

Alpha Lipoic Acid

Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.

DRUG

Metfomin

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2026-09-10
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630779 on ClinicalTrials.gov