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

2. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

210

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Haolin Zhang, PhD
  • Telefonnummer: +86 15611963539
  • E-post: zoe@bjmu.edu.cn

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100191
        • Rekruttering
        • Peking University Third Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina, 100080
        • Har ikke rekruttert ennå
        • Beijing Haidian Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Annen: Conventional Acupuncture
Participants receive conventional acupuncture according to a standardized treatment protocol, administered three times per week by qualified acupuncture physicians.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HOMA-IR level after 12 weeks of treatment
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HOMA-IR level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University Third Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juli 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

19. august 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

9. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PKUTH TCM
  • 2026-2-40912 (Annen identifikator: Beijing Municipal Health Commission)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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