Determining the anti-migraine effects of eicosapentaenoic acid in controlling migraine symptoms.
Design
Single-center, randomized, three-blind, phase three clinical trials of 60 patients with chronic migraine in equal numbers were assigned to two groups of eicosapentaenoic acid, placebo.
Settings and conduct
Patients' follow-up evaluators, statistical data analysts, and quality controllers are blinded. Executors of the interventions are excluded from this study and are prescribed based on the codes provided in sealed packages.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1) Patients with chronic migraine based on ICHD-3 criteria
2) Age between 18 to 50 years
3) Signing a written consent
Exclusion Criteria:
1) Any contraindications to use EPA, such as history of hypersensitivity reactions
2) Pregnancy
3) Nursing Mothers
4) Patients treated with antiplatelet or anticoagulant drugs.
5) Patients with a history of bleeding disorders.
Intervention groups
Patients in this study will be randomly divided into two groups, the intervention group will receive 2000 mg per day orally EPA and the control group, which will receive a placebo that is very similar in appearance and packaging to the drug sample.
Main outcome variables
The main outcome is the HIT-6 index and the secondary outcomes include 1) a questionnaire to assess pain during the day 3) a quality of life questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170608034390N9
Registration date:2022-05-11, 1401/02/21
Registration timing:prospective
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Hadi Esmaily
Name of organization / entity
SBMU
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
esmaily_hadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of eicosapentaenoic acid in patients with chronic migraine headache; a randomized controlled trial
Public title
evaluation of the efficacy of eicosapentaenoic acid in patients with chronic migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic migraine based on the ICHD-3 criteria
Ages between 18 and 50
Provide written consent
Exclusion criteria:
Contraindications to EPA such as allergies
Patients with a history of bleeding disorders
Patients with increased risk of bleeding
Pregnant patients
Lactating patients
Patients treated with antiplatelet or anticoagulant drugs
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After preparing the medicine and placebo, they will be packed in the same box by a clinical laboratory expert who is outside the researchers and the randomization code will be provided to them based on the Excel file extracted from Sealed Envelope software. The package will be transferred to the clinic and the codes will remain closed until the statistical analysis is performed. In this case, the present study will be a blind three-way study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researchers included in the study, including the physician who examines patient eligibility, the physician who examines the response to interventions, the statistical analyst of data, and the controller of study quality, are all blinded, but due to the different nature of interventions, the possibility of blinding There is no executor, so a sealed envelope containing the patient treatment code was sent to the relevant prescriber or neurologist who only performed the interventions and did not play a role in follow-up in the patients' eligibility review, treatment and outcome measurement processes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of
Street address
Central department of ministry of health and medical education, Simaye Iran st, Shahrak Ghods
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.149
Health conditions studied
1
Description of health condition studied
Chronic migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache impact test 6 (HIT-6)
Timepoint
The frequency, severity and duration of headaches are measured monthly for two months.
Method of measurement
Headache impact test 6 (HIT-6)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 2000 mg of EPA daily in the form of add on treatment, products are softgels containing 1000 mg of EPA-ethyl ester (EPA-EE) made by Yas Kavir Pharmaceutical Company in accordance to good manufacturing practice of pharmaceutical production and the placebo will contain 1000 mg of edible oil with the same shape, smell, taste and color. In both groups, patients will consume one soft gel twice a day after meals for 8 weeks.
Category
Treatment - Other
2
Description
Control group: first-line anti-migraine prophylactic agent and placebo soft gel(apparently similar with the EPA soft gels)