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RECRUITING
NCT07809503
NA

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

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-07-10

Completion Date

2028-12-31

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

OTHER

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.

BEHAVIORAL

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.

OTHER

Conventional Acupuncture

Participants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.

BEHAVIORAL

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.

Locations (2)

Beijing Haidian Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China