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.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (推定)
入学
210
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Haolin Zhang, PhD
- 電話番号：+86 15611963539
- メール：zoe@bjmu.edu.cn
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100191
- 募集
- Peking University Third Hospital
-
コンタクト：
- Haolin Zhang, PhD
- 電話番号：+86-10-82264627
- メール：zoe@bjmu.edu.cn
-
Beijing、Beijing Municipality、中国、100080
- まだ募集していません
- Beijing Haidian Hospital
-
コンタクト：
- Haolin Zhang, PhD
- 電話番号：+86-10-82264627
- メール：zoe@bjmu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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.
|
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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アクティブコンパレータ：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HOMA-IR level after 12 weeks of treatment
時間枠：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)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
HOMA-IR level
時間枠：Baseline (Week 0) and end of follow-up (Week 24)
|
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.
|
Baseline (Week 0) and end of follow-up (Week 24)
|
|
Area under the insulin concentration-time curve during the oral glucose tolerance test
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2026年7月10日
一次修了 (推定)
一次修了
2028年12月31日
研究の完了 (推定)
研究の完了
2028年12月31日
試験登録日
最初に提出
最初に提出
2026年8月19日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年9月2日
最初の投稿 (実際)
最初の投稿
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月9日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- PKUTH TCM
- 2026-2-40912 (その他の識別子：Beijing Municipal Health Commission)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。