|
Main
|
|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01687660 |
|
Date of registration:
|
31/08/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Acupuncture for Migraine Prophylaxis
AMP |
|
Scientific title:
|
A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment |
|
Date of first enrolment:
|
September 2012 |
|
Target sample size:
|
249 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01687660 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Fanrong Liang, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Chengdu University of Traditional Chinese Medicine |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age of a subject is between 18 and 65 years old(initially occured beneath the age of
50), male or female;
- in accordance with diagnosis of migraine without aura in International Classification
of Headache Disorders, ICHD-2, by IHS;
- 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
- with migraine history for over 1 year;
- be able and willing to finish the headache diary in baseline ;
- informed consent form must be signed by patient or lineal relative;
Exclusion Criteria:
- Patients who are unconscious, psychotic.
- Patients with aggravating tumor and other serious consumptive disease, and who are
subject to infection and bleeding.
- With serious primary illness or disease of cardiovascular, liver, renal,
gastrointestinal, hematological systems and so on.
- Pregnant women or women in lactation.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Unilateral Headache
|
|
Migraine Without Aura
|
|
Intervention(s)
|
|
Other: acupuncture
|
|
Primary Outcome(s)
|
|
frequency of migraine attacks
[Time Frame: 16th week after inclusion]
|
|
Secondary Outcome(s)
|
|
frequency of migraine attacks
[Time Frame: 4th and 24th week after inclusion]
|
|
headache severity
[Time Frame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion]
|
|
Secondary ID(s)
|
|
2012CB518501-2
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|