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Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS

2 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

210

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Haolin Zhang, PhD
  • Numéro de téléphone: +86 15611963539
  • E-mail: zoe@bjmu.edu.cn

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100191
        • Recrutement
        • Peking University Third Hospital
        • Contact:
          • Haolin Zhang, PhD
          • Numéro de téléphone: +86-10-82264627
          • E-mail: zoe@bjmu.edu.cn
      • Beijing, Beijing Municipality, Chine, 100080
        • Pas encore de recrutement
        • Beijing Haidian Hospital
        • Contact:
          • Haolin Zhang, PhD
          • Numéro de téléphone: +86-10-82264627
          • E-mail: zoe@bjmu.edu.cn

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Model-Guided Precision Acupuncture
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.
Comportemental: Personalized Lifestyle Intervention
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.
Comparateur actif: 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.
Autre: Conventional Acupuncture
Participants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.
Comportemental: Standard Lifestyle Intervention
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
HOMA-IR level after 12 weeks of treatment
Délai: End of treatment (Week 12)
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.
End of treatment (Week 12)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
HOMA-IR level
Délai: 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
Délai: Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
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.
Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Glycated hemoglobin level
Délai: Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Glycated hemoglobin (HbA1c) will be measured using the study site's routine clinical laboratory method.
Baseline (0 week), end of treatment (12 week) and end of follow-up (24week).
Serum anti-Müllerian hormone concentration
Délai: Baseline (Week 0), Week 12, and Week 24
Serum anti-Müllerian hormone (AMH) concentration will be measured using the study site's routine clinical laboratory method.
Baseline (Week 0), Week 12, and Week 24
Serum total cholesterol concentration
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum total cholesterol (TC) concentration will be measured using the study site's routine clinical laboratory method.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum triglyceride concentration
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum triglyceride (TG) concentration will be measured using the study site's routine clinical laboratory method.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum high-density lipoprotein cholesterol concentration
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum high-density lipoprotein cholesterol (HDL-C) concentration will be measured using the study site's routine clinical laboratory method.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum low-density lipoprotein cholesterol concentration
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Serum low-density lipoprotein cholesterol (LDL-C) concentration will be measured using the study site's routine clinical laboratory method.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Number of menstrual bleeding episodes
Délai: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
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.
During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Number of ovulations
Délai: During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
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.
During treatment (Weeks 1-12) and during follow-up (Weeks 13-24)
Body weight
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Body weight will be measured in kilograms at each assessment.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Body mass index
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist circumference
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist circumference will be measured in centimeters using the standardized study measurement procedure.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist-to-hip ratio
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference. A single dimensionless ratio will be reported for each assessment.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Modified Ferriman-Gallwey hirsutism score
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Polycystic Ovary Syndrome Questionnaire total score
Délai: Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
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.
Baseline (Week 0), end of treatment (Week 12), and end of follow-up (Week 24)
Number of participants with adverse events
Délai: From the first study intervention through the end of follow-up (Week 24)
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.
From the first study intervention through the end of follow-up (Week 24)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University Third Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

19 août 2026

Première soumission répondant aux critères de contrôle qualité

2 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PKUTH TCM
  • 2026-2-40912 (Autre identifiant: Beijing Municipal Health Commission)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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