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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 21 August 2017
Main ID:  ChiCTR-INR-17012003
Date of registration: 2017-07-15
Prospective Registration: Yes
Primary sponsor: Wuhan Puren Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Public title: Effect of low frequency electro-acupuncture (EA) on perimenopausal syndrome: study protocol of a double-blind, sham-controlled, randomized trial
Scientific title: Effect of low frequency electro-acupuncture (EA) on the life qulity of patient with perimenopausal syndrome: study protocol of a double-blind, sham-controlled, randomized trial
Date of first enrolment: 2017-09-01
Target sample size: the true acupuncture group:60; sham acupuncture group:60;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=20494
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Qing Wang   
Address:  1 Benxi Street, Qingshan District, Wuhan, Hubei, China
Telephone: +86 15002738336
Email: qingpin6686@126.com
Affiliation:  Department of Rehabilitation Center of Wuhan Puren Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Name: Qing Wang   
Address:  1 Benxi Street, Qingshan District, Wuhan, Hubei, China
Telephone: +86 15002738336
Email: qingpin6686@126.com
Affiliation:  Department of Rehabilitation Center of Wuhan Puren Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Key inclusion & exclusion criteria
Inclusion criteria: 1. Aged between 35 and 65 years;
2. Meet the Rotterdam diagnosis criteria of perimenopausal syndrome;
3. kupperman index >15 scores.

Exclusion criteria: 1. Patients who received other medications (such as anti-obesity medications, anti-diabetic medications, traditional Chinese medicine and so on) which influence reproductive function or metabolism within the past 3 months;
2. Patients who receive acupuncture treatment within the past 3 months;
3. patient with ovarian tumors or whose ovarian had been revoved;
4. patient with abnormal mental status;
5. patient combined with anyone of cardiovascular, cerebrovascular, liver and kidney and hematopoietic system serious primary diseases;
6. Patients who are unwilling to give written consent to the study.


Age minimum: 35
Age maximum: 65
Gender: Female
Health Condition(s) or Problem(s) studied
perimenopausal syndrome
Intervention(s)
the true acupuncture group:low frequency electro-acupuncture ; sham acupuncture group:sham acupuncture;
Primary Outcome(s)
sex hormones;Blood-lipid;CHQOL;MENQOL;Kupperman index;Zung-SAS;Zung-SDS;
Secondary Outcome(s)
wight;
Secondary ID(s)
AMCTR-IOR-17000072
Source(s) of Monetary Support
Self-raised funds
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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