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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:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-TRC-07000024 |
Date of registration:
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2007-11-21 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Acupuncture with different point selection methods in the treatment of migraine
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Scientific title:
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An assessment study of optimization design of acupuncture with different point selection methods in the treatment of migraine |
Date of first enrolment:
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2008-01-01 |
Target sample size:
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No acupuncture group:150;Bian Zheng group:150;Simulation group:150;Head puncture:150; |
Recruitment status: |
Completed |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=9501 |
Study type:
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Interventional study |
Study design:
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Randomized parallel controlled trial
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Phase:
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New Treatment Measure Clinical Study
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Countries of recruitment
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China
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Contacts
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Name:
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Yingkun Li
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Address:
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Chengdu university of traditional Chinese medicine
610041
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Telephone:
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+86 028 85402322 |
Email:
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monica_cai@126.com |
Affiliation:
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Name:
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Yujia Cai
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Address:
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Chinese Cochrane Center, West China Hospital, Sichuang University, No. 37 Guoxuexiang, Chengdu, China
610041
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Telephone:
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+86 0 13981833184 |
Email:
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monica_cai@126.com |
Affiliation:
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Chengdu University of Traditional Chinese Medicine, West China Hospital, Sichuang University, Chengdu Hospital of Integrated TCM & WM |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Migraine
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Intervention(s)
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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;
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Primary Outcome(s)
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Frequency of headache;Rate of no improvement;
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Secondary Outcome(s)
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Catabatic rate or degree;Quality of life;Wastage of antipain drugs;Changes of TCM "Zheng";Cast-effictive analysis;
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Source(s) of Monetary Support
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Ministry of Science and Technology of China
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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