Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT03546595|
Recruitment Status : Unknown
Verified December 2019 by Yan Li, Heilongjiang University of Chinese Medicine.
Recruitment status was: Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : December 26, 2019
The present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with PCOS.A total of 100 subjects will be enrolled into this study and will be randomized into two groups.
Auricular acupressure or sham auricular acupressure will be treated for three months. The primary outcome is the whole body insulin action assessed with HOMA-IR.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Insulin Resistance||Other: Auricular acupoints acupressure Other: Sham auricular acupoints acupressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
|Experimental: Auricular acupoints acupressure||
Other: Auricular acupoints acupressure
The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
|Sham Comparator: Sham auricular acupoints acupressure||
Other: Sham auricular acupoints acupressure
The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
- Homeostasis model assessment-insulin resistance (HOMA-IR) [ Time Frame: 3 month ]HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.
- Testosterone(T) [ Time Frame: 3 month ]
- Androstadienedione (AND) [ Time Frame: 3 month ]
- Sex hormone-binding globulin (SHBG) [ Time Frame: 3 month ]
- Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 3 month ]
- Follicle stimulating hormone (FSH) [ Time Frame: 3 month ]
- Luteinizing hormone (LH) [ Time Frame: 3 month ]
- Estradiol (E2) [ Time Frame: 3 month ]
- Weight [ Time Frame: 3 month ]
- Waist/hip circumference [ Time Frame: 3 month ]
- BMI [ Time Frame: 3 month ]
- FG score [ Time Frame: 3 month ]
- Acne [ Time Frame: 3 month ]
- Short-Form Health Survey (SF-36) [ Time Frame: 3 month ]
- The Chinese Quality of Life questionnaire (ChQoL) [ Time Frame: 3 month ]
- Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ) [ Time Frame: 3 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546595
|First Affiliated Hospital, Heilongjiang University of Chinese Medicine|
|Harbin, Heilongjiang, China, 150040|