Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients (ALA-MYO-PCOS)
2 juni 2026 uppdaterad av: Ahmed Abdelkader, Beni-Suef University
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
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
180
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ahmed A Abdelkader, Lecturer Assistant
- Telefonnummer: +201050095206
- E-post: ahmed.abdelkader@hu.edu.eg
Studera Kontakt Backup
- Namn: Marwa Mohsen Mahmoud, Lecturer
- Telefonnummer: +201202203223
- E-post: Marwa.Mohsen@pharm.bsu.edu.eg
Studieorter
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypten
- Rekrytering
- Faculty of medicine, Cairo University
-
Kontakt:
- Hesham ElShaer, Professor
- Telefonnummer: +0201223130881
- E-post: dr.heshamelshaer@hotmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Myo-Inositol + Folic Acid
Participants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months.
|
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.
|
|
Experimentell: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid
Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily for 6 months.
|
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.
|
|
Experimentell: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin
Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily and metformin titrated up to 1500 mg/day over 2 weeks for 6 months.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ovulation Rate
Tidsram: From baseline to 6 months
|
Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.
|
From baseline to 6 months
|
|
Menstrual Cycle Regularity
Tidsram: From baseline to 6 months
|
Proportion of participants achieving menstrual cycle regularity, defined as cycle length between 21 and 35 days for at least two consecutive cycles during the study period.
|
From baseline to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum Prolactin Levels
Tidsram: Baseline, 3 months, and 6 months
|
Change in serum prolactin levels measured in ng/mL using standard laboratory assays.
|
Baseline, 3 months, and 6 months
|
|
Body Mass Index (BMI)
Tidsram: Baseline, 3 months, and 6 months
|
Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).
|
Baseline, 3 months, and 6 months
|
|
Serum Triglycerides
Tidsram: Baseline, 3 months, and 6 months
|
Change in fasting serum triglyceride levels measured in mg/dL.
|
Baseline, 3 months, and 6 months
|
|
Low-Density Lipoprotein (LDL) Cholesterol
Tidsram: Baseline, 3 months, and 6 months
|
Change in serum LDL cholesterol levels measured in mg/dL.
|
Baseline, 3 months, and 6 months
|
|
High-Density Lipoprotein (HDL) Cholesterol
Tidsram: Baseline, 3 months, and 6 months
|
Change in serum HDL cholesterol levels measured in mg/dL.
|
Baseline, 3 months, and 6 months
|
|
Fasting Blood Glucose
Tidsram: Baseline, 3 months, and 6 months
|
Change in fasting blood glucose levels measured in mg/dL after an overnight fast.
|
Baseline, 3 months, and 6 months
|
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsram: Baseline, 3 months, and 6 months
|
Change in insulin resistance calculated using the HOMA-IR index based on fasting glucose and insulin levels.
|
Baseline, 3 months, and 6 months
|
|
Testosterone
Tidsram: Baseline, 3 months, and 6 months
|
Change in serum testosterone levels measured in ng/dL.
|
Baseline, 3 months, and 6 months
|
|
Serum Luteinizing Hormone (LH)
Tidsram: Baseline, 3 months, and 6 months
|
Change in serum luteinizing hormone levels measured in mIU/mL using standard laboratory assays.
|
Baseline, 3 months, and 6 months
|
|
Serum Follicle-Stimulating Hormone (FSH)
Tidsram: Baseline, 3 months, and 6 months
|
Change in serum follicle-stimulating hormone levels measured in mIU/mL using standard laboratory assays.
|
Baseline, 3 months, and 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 mars 2026
Primärt slutförande (Beräknad)
10 september 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
5 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N-52-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.
Tidsram för IPD-delning
Data will be available beginning 6 months after publication of the study results and will be available for up to 2 years.
Kriterier för IPD Sharing Access
Access will be granted to qualified researchers upon reasonable request to the principal investigator.
Requests will be reviewed based on scientific merit and ethical considerations.
Data will be provided after approval and signing of a data sharing agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .