Migraine
Conditions
Keywords
Migraine, Ginger, Prophylactic treatment
Brief summary
The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.
Detailed description
Patients with the diagnosis of migraine according to the IHS criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.
Interventions
Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks.
Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
* Aged between 18 and 60 years old; * Migraine diagnosis; * Agree to sign the informed consent.
Exclusion criteria
* Patients with headaches not characterized as migraine; * Pregnant or lactating women; * Fertile and sexually active women who do not use contraception; * Abuse of painkillers, alcohol or other drugs; * People with hypersensitivity to ginger compounds; * People with severe neurological diseases (e.g. epilepsy) * People in use of anticoagulant drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the frequency of migraine attacks. | 12 weeks | Frequency of migraine attacks will be assessed by headache diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in migraine impact in the last month. | 4 weeks | Migraine impact will be assessed by HIT-6. |
| Change in migraine impact in the last three months. | 12 weeks | Migraine impact will be assessed by MIDAS. |
| Changes in the serum levels of biomarkers. | 12 weeks | Biomarkers: inflammatory mediators and neurotrophic factors |
| Changes in Resting Energy Expenditure | 4, 8 and 12 weeks | Resting Energy Expenditure will be assessed by calorimeter |
Countries
Brazil