Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS
2026年9月2日 更新者：Peking University Third Hospital
MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis
This study is designed as a prospective, multicenter, parallel-group randomized controlled trial to evaluate the effectiveness of a "precision acupuncture + personalized lifestyle" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS).
Compared with "conventional acupuncture + standard lifestyle intervention," the study will primarily assess changes in the homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment.
The safety of the intervention, improvements in endocrine and metabolic profiles, menstrual and ovulatory outcomes, psychological status, quality of life, and health-economic outcomes will also be evaluated.
The study aims to provide evidence for establishing an intelligent and individualized clinical management model for PCOS.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
210
阶段
- 不适用
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：Haolin Zhang, PhD
- 电话号码：+86 15611963539
- 邮箱：zoe@bjmu.edu.cn
学习地点
-
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100191
- 招聘中
- Peking University Third Hospital
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接触：
- Haolin Zhang, PhD
- 电话号码：+86-10-82264627
- 邮箱：zoe@bjmu.edu.cn
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Beijing、Beijing Municipality、中国、100080
- 尚未招聘
- Beijing Haidian Hospital
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接触：
- Haolin Zhang, PhD
- 电话号码：+86-10-82264627
- 邮箱：zoe@bjmu.edu.cn
-
-
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:
- Aged18-40 years, inclusive.
- Body mass index (BMI) of 25-40 kg/m², inclusive.
- Meeting the 2003 Rotterdam diagnostic criteria for polycystic ovary syndrome (PCOS), defined by the presence of at least two of the following three criteria: Oligo-ovulation or anovulation; Clinical and/or biochemical signs of hyperandrogenism; Polycystic ovarian morphology on ultrasonography.
- Willing to participate voluntarily in the study, able to understand the study procedures, and able to provide written informed consent.
Exclusion Criteria:
- Presence of hyperandrogenemia due to other causes, such as hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, or exogenous androgen use.
- Presence of renal disease (creatinine clearance <60 mL/min), hepatic impairment, autoimmune disease, or malignancy.
- Type 1 diabetes mellitus or glycated hemoglobin (HbA1c) >53 mmol/mol (7%). - Use, within the past 3 months, of medications that may affect study assessments, including glucocorticoids, insulin, glucose-lowering agents such as acarbose, antidepressants, hormonal contraceptives, ovulation-inducing agents, or other relevant medications.
- Blood pressure >160/100 mmHg.
- Currently pregnant or breastfeeding, pregnancy within the past 6 months, or planning to become pregnant during the study period.
- Having received continuous acupuncture treatment for at least 2 months prior to study treatment.
- Daily smoking or alcohol consumption.
- Presence of language barriers, psychiatric disorders, or other conditions that may impair the participant's ability to understand the study, comply with the intervention, or complete follow-up assessments.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Precision Acupuncture Plus Personalized Lifestyle Intervention
Participants receive model-guided precision acupuncture, with treatment frequency determined by insulin resistance risk and reassessed every 4 weeks, together with a personalized lifestyle intervention based on multimodal data and individualized glucose-response prediction.
The treatment period is 12 weeks.
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Acupuncture treatment is guided by a multimodal risk-stratification model using clinical and noninvasive indicators.
Participants receive one of two standardized alternating acupuncture prescriptions with manual and 2-Hz electroacupuncture for 30 minutes.
Treatment frequency is adjusted according to insulin resistance risk: three sessions per week for high risk, two sessions per week for moderate risk, and one session per week for low risk.
Risk is reassessed every 4 weeks during the 12-week treatment period.
Participants receive personalized dietary and lifestyle guidance generated from multimodal data, including dietary images, continuous glucose monitoring data, traditional Chinese medicine constitution, body mass index, body fat percentage, blood pressure, and heart rate.
Foods are dynamically classified as green, orange, or red according to predicted individual glucose responses, and recommendations are adjusted throughout the 12-week intervention.
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有源比较器：Conventional Acupuncture Plus Lifestyle Intervention
Participants receive conventional acupuncture together with standard lifestyle management, including exercise and nutritional guidance delivered and monitored through the PCOS health management system.
The treatment period is 12 weeks.
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Participants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.
Participants receive standard exercise and nutritional guidance through the PCOS health management system.
Exercise is guided and monitored using step-count data, while dietary prescriptions and remote health guidance are delivered through a mobile application and computer-based platform.
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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 |
|---|---|---|
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HOMA-IR level after 12 weeks of treatment
大体时间：End of treatment (Week 12)
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Fasting venous blood samples will be collected to measure fasting plasma glucose and fasting insulin.
HOMA-IR will be calculated using the following formula: HOMA-IR = fasting plasma glucose (mmol/L) × fasting insulin (μIU/mL) / 22.5.
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End of treatment (Week 12)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HOMA-IR level
大体时间：Baseline (Week 0) and end of follow-up (Week 24)
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Fasting venous blood samples will be collected to measure fasting plasma glucose and fasting insulin.
HOMA-IR will be calculated using the following formula: HOMA-IR = fasting plasma glucose (mmol/L) × fasting insulin (μIU/mL) / 22.5.
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Baseline (Week 0) and end of follow-up (Week 24)
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Area under the insulin concentration-time curve during the oral glucose tolerance test
大体时间：Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
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The area under the insulin concentration-time curve (insulin AUC) will be calculated from insulin concentrations measured during the oral glucose tolerance test (OGTT).
A single insulin AUC value will be reported for each assessment.
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Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
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Glycated hemoglobin level
大体时间：Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
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Glycated hemoglobin (HbA1c) will be measured using the study site's routine clinical laboratory method.
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Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
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Serum anti-Müllerian hormone concentration
大体时间：Baseline (Week 0), Week 12, and Week 24
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Serum anti-Müllerian hormone (AMH) concentration will be measured using the study site's routine clinical laboratory method.
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Baseline (Week 0), Week 12, and Week 24
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Serum total cholesterol concentration
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum total cholesterol (TC) concentration will be measured using the study site's routine clinical laboratory method.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum triglyceride concentration
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum triglyceride (TG) concentration will be measured using the study site's routine clinical laboratory method.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum high-density lipoprotein cholesterol concentration
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum high-density lipoprotein cholesterol (HDL-C) concentration will be measured using the study site's routine clinical laboratory method.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum low-density lipoprotein cholesterol concentration
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Serum low-density lipoprotein cholesterol (LDL-C) concentration will be measured using the study site's routine clinical laboratory method.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Number of menstrual bleeding episodes
大体时间：During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
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articipants will record menstrual bleeding using menstrual cycle diaries.
The number of menstrual bleeding episodes will be summarized separately during the 12-week treatment period and the 12-week follow-up period.
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During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
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Number of ovulations
大体时间：During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
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Ovulatory status will be assessed using menstrual cycle records.
When clinically necessary, gynecologic ultrasonography will be used to assess follicular development and endometrial changes.
The number of ovulations will be summarized separately during the treatment and follow-up periods.
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During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
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Body weight
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Body weight will be measured in kilograms at each assessment.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Body mass index
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Waist circumference
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Waist circumference will be measured in centimeters using the standardized study measurement procedure.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Waist-to-hip ratio
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference.
A single dimensionless ratio will be reported for each assessment.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Modified Ferriman-Gallwey hirsutism score
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Hirsutism will be assessed using the modified Ferriman-Gallwey score.
Terminal hair growth in nine androgen-sensitive body areas is scored from 0 to 4, producing a total score ranging from 0 to 36.
Higher scores indicate more severe hirsutism.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Polycystic Ovary Syndrome Questionnaire total score
大体时间：Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Health-related quality of life will be assessed using the 30-item Polycystic Ovary Syndrome Questionnaire (PCOSQ) described in the protocol.
Each item is scored from 1 to 7. The total score is calculated as the sum of all item scores and ranges from 30 to 210, with higher scores indicating better health-related quality of life.
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Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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Number of participants with adverse events
大体时间：From the first study intervention through the end of follow-up (Week 24)
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Adverse events will be recorded at each study visit and classified as mild, moderate, or severe.
Events of interest include hypoglycemia, defined as blood glucose below 3.9 mmol/L; acute diabetic complications; and acupuncture-related events such as bleeding, hematoma, fainting, needling-site pain, and elevated blood pressure.
The number and percentage of participants experiencing at least one adverse event will be reported.
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From the first study intervention through the end of follow-up (Week 24)
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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7月10日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年8月19日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PKUTH TCM
- 2026-2-40912 (其他标识符：Beijing Municipal Health Commission)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared.
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
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