Migraine. Migraine
Conditions
Interventions
Intervention 1: Intervention group: Two capsules of black grape seed extract daily (containing 100 mg of black grape seed extract, Daru Pajhuh-e-Jaber company) for eight weeks. Intervention 2: Control
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients who are willing to participate in the study Migraine diagnosis by a neurologist based on the International Classification of Headache Disorders-3 (ICHD-3) Age 18 to 60 years Having at least one migraine attack per month Body mass index between 18.5 to 30
Exclusion criteria
Exclusion criteria: Suffering from chronic kidney diseases, cancer, and other neurological disorders Suffering from tension-type headaches Change in the type of medicine used and its dosage during the last month Pregnancy and lactation Taking supplements containing antioxidants and black grape seed extract in the last 3 months Following a special diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of total antioxidant capacity (TAC). Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (colorimetric method).;Migraine frequency. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Question / Number of attacks per month.;Duration of migraine headache. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Question/ average duration of migraine attacks per headache (hours).;Severity of migraine attacks. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Visual Analogue Scale (VAS).;Migraine disability. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Headache Impact Test-6 questionnaire (HIT-6).;Calcitonin gene-related peptide (CGRP) serum level. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (ELISA).;Vascular cell adhesion molecule-1 (VCAM-1) serum level. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (ELISA).;Malondialdehyde (MDA) serum level. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Blood test (colorimetric method). | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life in migraine patients. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Migraine-Specific Quality of Life (MSQ).;Depression. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire (DASS-21).;Anxiety. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire (DASS-21).;Stress. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire (DASS-21).;Blood pressure. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: Mercury barometer.;Anthropometric indices. Timepoint: Before the start of the intervention and 60 days after the start of the intervention. Method of measurement: A digital scale and standard stadiometer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Gholamreza Askari
Esfahan University of Medical Sciences
Outcome results
None listed