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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: 18 April 2017
Main ID:  ChiCTR-IPR-15007383
Date of registration: 2015-11-12
Prospective Registration: No
Primary sponsor: Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture & Moxibustion; Acupuncture & Moxibustion Institute, Hubei University of Chinese Medicine
Public title: Effects of Acupuncture and Moxibustion on Heart Rate Variability in Patients with Chronic Fatigue Syndrome
Scientific title: A Randomized Control Trial of Acupuncture and Moxibustion on Chronic Fatigue Syndrome and Heart Rate Variability
Date of first enrolment: 2014-10-01
Target sample size: acupuncture group:15;moxibustion:15;control group:15;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=12452
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Pilot study
Countries of recruitment
Austria
Contacts
Name: Fengxia LIang   
Address:  1 Tanhualin, Wuchang District, Wuhan, China 430061
Telephone: +86 18971371818
Email: fxliang5@hotmail.com
Affiliation: 
Name: Qing Shu   
Address:  1 Tanhualin, Wuchang District, Wuhan, China 430061
Telephone: +86 13971081682
Email: shuqingj@outlook.com
Affiliation:  Hubei University of Chinese Medicine
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients with CFS who were 18 to 65 years old;
2. Patients who met the diagnostic criteria for CFS that were published by the Centers for Disease Control and Prevention in the United States;
3. Patients who had no skin injuries at the acupoints (ST36 (Zusanli), CV4 (Guanyuan)).

Exclusion criteria: 1. Participants who could not accept and were afraid of acupuncture in the acupuncture group;
2. Participants who suffered from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of the liver, kidney, and the hematopoietic system;
3. Participants who suffered from a mental health disorder, Alzheimer's disease, or cancer;
4. Participants who had taken Chinese herbal medicine during the previous 4 weeks and preceding the investigation;
5. Pregnant women and nursing mothers;
6. Participants who suffered from thrombocytopenia and abnormalities of blood coagulation;
7. Participants with a history of alcohol or drug abuse.


Age minimum: 18
Age maximum: 65
Gender: Male
Health Condition(s) or Problem(s) studied
Chronic Fatigue Syndrome
Intervention(s)
acupuncture group:acupuncture at ST36, CV4;moxibustion:moxibustion at ST36, CV4;control group:acupuncture at ST36, CV4;
Primary Outcome(s)
Fatigue Assessment Instrument;
Secondary Outcome(s)
mean HR;SDNN;total HRV;LF;HF;lg LF/HF;
Secondary ID(s)
Source(s) of Monetary Support
Hubei Provincial Collaborative Innovation Center of Preventive Treatment by A;Eurasia Pacific Uninet (project EPU 04/2015); Austrian Federal Ministries of Research, Science and Economy and of Health.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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