The RCT of Acupuncture on PCOS Combined With IR
NCT02491333 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342
Last updated 2022-03-21
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
- Polycystic Ovary Syndrome
- Insulin Resistance
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 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 - 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
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