Ginger Capsules for the Prophylactic Treatment of Migraine

Study Overview
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Brief Summary
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The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

Detailed Description
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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.

Official Title
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Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment

Conditions
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Migraine

Intervention / Treatment
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* Other: Extract of ginger
* Other: Cellulose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extract of ginger<br>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. | Other: Extract of ginger<br>* 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.<br>|
| Placebo Comparator: Cellulose<br>Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks. | Other: Cellulose<br>* Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the frequency of migraine attacks. | Frequency of migraine attacks will be assessed by headache diary. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in migraine impact in the last month. | Migraine impact will be assessed by HIT-6. | 4 weeks | 
| Change in migraine impact in the last three months. | Migraine impact will be assessed by MIDAS. | 12 weeks | 
| Changes in the serum levels of biomarkers. | Biomarkers: inflammatory mediators and neurotrophic factors | 12 weeks | 
| Changes in Resting Energy Expenditure | Resting Energy Expenditure will be assessed by calorimeter | 4, 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Ginger, Prophylactic treatment