The RCT of Acupuncture on PCOS Combined With IR

NCT02491333 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2022-03-21

No results posted yet for this study

Summary

The objectives of this randomized controlled trial are to compare insulin sensitivity following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.

Conditions

Interventions

OTHER

true acupuncture

True acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.

OTHER

sham acupuncture

Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.

DRUG

metformin

Metformin will be given at 0.5g/times, 3 times one day and for 4 month.

DRUG

Placebo metformin

Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Hongxia Ma · The First Affiliated Hospital of Guangzhou Medical University

  • Juan Li, PhD · The First Affiliated Hospital of Guangzhou Medical University

  • Maohua Lai, PhD · The First Affiliated Hospital of Guangzhou Medical University

  • Hua Liu, Master · The First Affiliated Hospital of Guangzhou Medical University

  • Wanting Wu, Master · The First Affiliated Hospital of Guangzhou Medical University

  • Ernest HY NG, PhD · The University of Hong Kong

  • Elisabet Stener-Victorin, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491333 on ClinicalTrials.gov