Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients (ALA-MYO-PCOS)
2026年6月2日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
180
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ahmed A Abdelkader, Lecturer Assistant
- 电话号码：+201050095206
- 邮箱：ahmed.abdelkader@hu.edu.eg
研究联系人备份
- 姓名：Marwa Mohsen Mahmoud, Lecturer
- 电话号码：+201202203223
- 邮箱：Marwa.Mohsen@pharm.bsu.edu.eg
学习地点
-
-
Cairo Governorate
-
Cairo、Cairo Governorate、埃及
- 招聘中
- Faculty of medicine, Cairo University
-
接触：
- Hesham ElShaer, Professor
- 电话号码：+0201223130881
- 邮箱：dr.heshamelshaer@hotmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
实验性的：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.
|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ovulation Rate
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum Prolactin Levels
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月10日
初级完成 (估计的)
2026年9月10日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年6月5日
上次提交的符合 QC 标准的更新
2026年6月2日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- N-52-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.
IPD 共享时间框架
Data will be available beginning 6 months after publication of the study results and will be available for up to 2 years.
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.