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IRCT20170608034390N9 IRCT 2022-05-11 Shahid Beheshti University of Medical Sciences evaluation of the efficacy of eicosapentaenoic acid in patients with chronic migraine headache Evaluation of the efficacy of eicosapentaenoic acid in patients with chronic migraine headache; a randomized controlled trial 2022-06-22 anticipated 60 Complete https://irct.ir/trial/58531 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Chronic migraine. Intervention 1: 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. Intervention 2: Control group: first-line anti-migraine prophylactic agent and placebo soft gel(apparently similar with the EPA soft gels). Yes - There is a plan to make this available What will be shared: Potentially the whole data is published after participants become unidentified. When: The access Starts in 6 months period after publishing of the results To whom: Researchers working in academic and industrial institutions. Conditions: t can be used to carry out research work. Where to obtain: Dr. Hadi Esmaily, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. How to obtain: It will be available with sending a request by email to corresponding author (Esmaily_hadi@sbmu.ac.ir). Comments:
public Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with chronic migraine based on the ICHD-3 criteria Ages between 18 and 50 Provide written consent 18 years 50 years Both 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 G43 Migraine Treatment - Other Placebo 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. Control group: first-line anti-migraine prophylactic agent and placebo soft gel(apparently similar with the EPA soft gels) 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). Shahid Beheshti University of Medical Sciences Approved 2021-09-25 Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Central department of ministry of health and medical education, Simaye Iran st, Shahrak Ghods Tehran Tehran Iran (Islamic Republic of)