The aim of this study is to evaluate the efficacy of Coenzyme Q10 in the prophylactic treatment of migraine headache. Inclusion criteria are: A definitive diagnosis of migraine based on international headache society criteria and having at least one headache per week or 4 per month. Having another serious disease such as diabetes, hypertension, thyroid disease, or asthma that would interfere with migraine or its preventive treatment are the main exclusion criteria as well as using COQ10 by the patient during the last month before study involvement. This study involves 40 patients with definite diagnosis of migraine headache as the case group who will receive100 mg/ day CoQ10 in addition to their previous prophylactic treatment and 40 control patients with migraine who will continue their traditional anti-migraine treatment. Patients will be visited at 1, 3 and 6 months intervals for evaluation of primary outcomes including severity of the headache, duration of pain attacks, and frequency of headaches as well as presence of associated symptoms such as nausea and vomiting, photophobia and etc.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083118992N1
Registration date:2015-01-29, 1393/11/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-29, 1393/11/09
Registrant information
Name
Seyed Mohsen Soltani Sabi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 9828
Email address
soltanism901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
research grunt by the deputy of research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-09-12, 1393/06/21
Expected recruitment end date
2015-09-12, 1394/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of CO Q10 in the prophylactic treatment of patient with migraine headache
Public title
Study of the effecacy of CO Q10 in the prophylactic tretment of migraine
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: A definitive diagnosis of migraine based on IHS criteria; having at least one headache per week or 4 per month or having less frequent attacks providing that there is another indication for prophylactic treatment such as suffering from long-lasting disabling attacks; signing informed consent forms by the patient .Exclusion criteria: Having another serious disease such as diabetes, hypertension, thyroid disease, or asthma that interferes with migraine or its preventive treatment; using COQ10 during the last month before study involvement by the patient for another reason; consuming drugs with potential effects of aggravating migraine attacks such as OCP, nitrate compounds, vasodilatators, ...; failure to follow-up the patient for 6 months.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
00000
Secondary trial Id
00000
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Mashhad University of Medical Sciences
Street address
Qureshi Building, Daneshgah Avenue,Mashhad
City
Mashhad
Postal code
91375-345
Approval date
2013-09-16, 1392/06/25
Ethics committee reference number
920108
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
g43
ICD-10 code description
Migraine without aura [common migraine]Migraine with aura [classical migraine]
Primary outcomes
1
Description
headache
Timepoint
1,3,6 months
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Associated symptoms of Migraine
Timepoint
1.3.6 month
Method of measurement
Questionnaires and Interview
Intervention groups
1
Description
control group will receive common treatment for migraine prophylaxis
Category
Treatment - Drugs
2
Description
intervention group will use CoQ10 for six months in addition to their traditional medicines. COQ10 will prescribe with a dose of 100 mg per day orally