Migraine. G43
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The patient must agree to participate in the study. The diagnosis of migraine must be confirmed by a neurologist according to the ICHD-3 criteria. The patient must be aged between 20 and 50 years.
Exclusion criteria
Exclusion criteria: Non-compliance with dietary recommendations and supplements, defined as consuming less than 80% of the prescribed supplement. Development of a reaction or sensitivity to the prescribed supplement. Failure to attend follow-up visits at different stages of the study. Diagnosis of tension-type headaches. Diagnosis of gastrointestinal disorders such as Crohn’s disease or ulcerative colitis, or other neurological disorders. Pregnancy or lactation. Use of nutritional supplements, including probiotics or prebiotics, within the last three months. Following a special diet. Use of antibiotics or antacid drugs within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms of migraine (severity, frequency, duration of migraine attacks). Timepoint: At baseline and after 12 weeks. Method of measurement: Visual Analogue Scale (VAS) questionnaire and clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression, stress, anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21 questionnaire.;Quality of Life in Migraine Patients. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life (MSQ) questionnaire.;Physical activity. Timepoint: At baseline and after 12 weeks. Method of measurement: International Physical Activity Questionnaire (IPAQ).;Anthropometric indices. Timepoint: At baseline and after 12 weeks. Method of measurement: Seca scale and portable stadiometer.;Serum Nitric Oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co.;Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co.;Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum lactate levels. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co.;Serum malondialdehyde levels. Timepoint: At baseline and after 12 weeks. Method of measurement: Biochemical kit of KiaZist Co.;Serum interleukin-6 levels. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Esfahan University of Medical Sciences