Randomized Controlled Trial of Treating Migraine With Acupuncture - Full Text View

Sponsored by:	Chengdu University of Traditional Chinese Medicine
Information provided by:	Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00599586

Purpose

The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Condition	Intervention
Migraine	Other: acupuncture

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Acupuncture Migraine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial of Treating Migraine With Acupuncture

Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:

number of days with migraine [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
frequency of migraine attacks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Migraine-Specific Quality-of-Life Questionnaire [ Time Frame: a month ] [ Designated as safety issue: Yes ]
Transcranial Doppler Sonography [ Time Frame: a month ] [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental specific acupoints of Shaoyang meridians	Other: acupuncture Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
2: Experimental Non-specific acupoints of Shaoyang meridians	Other: acupuncture Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
3: Experimental Acupoints of other meridians	Other: acupuncture Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
4: Sham Comparator Non-acupoints	Other: acupuncture Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

Detailed Description:

The purpose of the study is to testify whether acupuncture is effective for migraine, through treating migraine patients for a month, using different acupoints according to literatures of treating migraine with acupuncture, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age of a subject is older than 18 and is younger than 65.(The subject is younger than 50 when he was ill for the first time.)
Consistent with the diagnostic criteria of Premonitory Migraine and Non- Premonitory Migraine.
Attacks of migraine are equal to or more than 2 times in the last three months.
With more than one year history of migraine
Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

With serious protopathy or disease of cardiovascular, liver, renal,gastrointestinal, hematological systems and so on.
Psychotic，patients with allergic constitution or easily getting infected or bleeding.
Patients have used drugs for preventing migraine in the last four weeks.
Pregnant women or women in lactation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599586

Contacts

Contact: Liang F rong, master

8613608058216

acuresearch@126.com

Locations

China, SiChuan
Chengdu University of TCM	Recruiting
chengdu, SiChuan, China, 610075
Contact: Liang F rong, master 8613608058216 acuresearch@126.com
Sub-Investigator: Zheng Hui, MD

Sponsors and Collaborators

Chengdu University of Traditional Chinese Medicine

Investigators

Study Chair:

Liang F rong, master

Chengdu University of TCM

More Information

funded by 973 programme of china This link exits the ClinicalTrials.gov site

Responsible Party:	Acupuncture & Tuina college of chengdu univeristy of TCM ( Liang Fanrong )
Study ID Numbers:	2006CB5045011, 2006CB5045011
Study First Received:	January 3, 2008
Last Updated:	December 27, 2008
ClinicalTrials.gov Identifier:	NCT00599586
Health Authority:	China: Ethics Committee

Keywords provided by Chengdu University of Traditional Chinese Medicine:

migraine
acupuncture
efficacy

safety
meridian
acupoint

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009