Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS
2026년 9월 2일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
210
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Haolin Zhang, PhD
- 전화번호: +86 15611963539
- 이메일: zoe@bjmu.edu.cn
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100191
- 모병
- Peking University Third Hospital
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연락하다:
- Haolin Zhang, PhD
- 전화번호: +86-10-82264627
- 이메일: zoe@bjmu.edu.cn
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Beijing, Beijing Municipality, 중국, 100080
- 아직 모집하지 않음
- Beijing Haidian Hospital
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연락하다:
- Haolin Zhang, PhD
- 전화번호: +86-10-82264627
- 이메일: zoe@bjmu.edu.cn
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HOMA-IR level after 12 weeks of treatment
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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HOMA-IR level
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 7월 10일
기본 완료 (추정된)
기본 완료
2028년 12월 31일
연구 완료 (추정된)
연구 완료
2028년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 19일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 9월 2일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PKUTH TCM
- 2026-2-40912 (기타 식별자: Beijing Municipal Health Commission)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared.
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .