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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-TRC-07000024
Date of registration: 2007-11-21
Prospective Registration: Yes
Primary sponsor: Chengdu University of Traditional Chinese Medicine
Public title: Acupuncture with different point selection methods in the treatment of migraine
Scientific title: An assessment study of optimization design of acupuncture with different point selection methods in the treatment of migraine
Date of first enrolment: 2008-01-01
Target sample size: No acupuncture group:150;Bian Zheng group:150;Simulation group:150;Head puncture:150;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=9501
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Yingkun Li   
Address:  Chengdu university of traditional Chinese medicine 610041
Telephone: +86 028 85402322
Email: monica_cai@126.com
Affiliation: 
Name: Yujia Cai   
Address:  Chinese Cochrane Center, West China Hospital, Sichuang University, No. 37 Guoxuexiang, Chengdu, China 610041
Telephone: +86 0 13981833184
Email: monica_cai@126.com
Affiliation:  Chengdu University of Traditional Chinese Medicine, West China Hospital, Sichuang University, Chengdu Hospital of Integrated TCM & WM
Key inclusion & exclusion criteria
Inclusion criteria: 1. male or female non-premonitory migraine patients between 18 and 65 years old, period of remission or onset;
2. apart from the diagnosis criteria according to ICHD-2, a diagnosis standard by traditional Chinese medicine theory must be fulfilled. ICHD-2 diagnosis criteria according to International Classification of Headache Disorders by HIS:(1) at least 5 headache attacks by history, and consistent with the (2) to (4) below:(2) last between 4 to 72 hours;
3. consistent with at least two of the following:
(1) unilateral location;
(2) pulsatility;
(3) moderate to severe degree;
(4) exacerbated by daily activities;
4. consistent with at least one of the following during one episode:
(1) nausea and/or vomiting;
(2) photophobia and/or phonophobia.
5. other secondary causes excluded. Diagnosis criteria by traditional Chinese medicine theory:
(1) Ganyang Shangkang Headache signsChief signs: headache, irritability, red eyes, bitter mouth.Secondary signs: flushing, dry mouth, red tongue, yellow Tai, Xuan pulse;
(2) Yuxue headache signs: Chief signs: fixed, persistent, pricking headache; Secondary signs: purple tongue, thin and light Tai, Chen or Xi pulse.

Exclusion criteria: 1. pregnancy or breast feeding period;
2. complicated with severe cerebral, liver, kidney, or hematopoietic system diseases, or Parkinson's disease, extra-pyramidal disorders, or mental defects, hypertension;
3. special migraine involvement, such as ophthalmoplegic migraine;
4. intake of migraine medication in the past month before inclusion, or abuse of such medication, i.e., intake of migraine medication for more than 10 days per month;
5. poor treatment compliance, such as fear of acupuncture; or difficult follow-up, such as living too afar without contact.


Age minimum: 15
Age maximum: 70
Gender: Both
Health Condition(s) or Problem(s) studied
Migraine
Intervention(s)
No acupuncture group:Anti-pain treatment by medicine;Bian Zheng group:Selection of puncture points will depends on the "Zheng". Electronic stimulating;Simulation group:Superficial puncture without "De Qi" and no electronic stimulating;Head puncture:Selection of acupuncture points and puncture methods based on WHO recommendation. Electronic stimulating;
Primary Outcome(s)
Frequency of headache;Rate of no improvement;
Secondary Outcome(s)
Catabatic rate or degree;Quality of life;Wastage of antipain drugs;Changes of TCM "Zheng";Cast-effictive analysis;
Secondary ID(s)
Source(s) of Monetary Support
Ministry of Science and Technology of China
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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