Ginger Capsules for the Acute Treatment of Migraine Attacks

Study Overview
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Brief Summary
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The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.

Detailed Description
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Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.

Official Title
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Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks

Conditions
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Migraine

Intervention / Treatment
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* Dietary Supplement: Extract of ginger
* Other: Cellulose
* Drug: Intravenous ketoprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine diagnosis for at least one year; Migraine attack with moderate or severe pain intensity; One to six migraine attacks per month. 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 drugs; People with hypersensitivity to ginger; People with other neurological diseases; People in use of anticoagulant drugs; People who have started the disease after 50 years old.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extract of ginger<br>People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg). | Dietary Supplement: Extract of ginger<br>* People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).<br>* Other names: Phytotherapy;Drug: Intravenous ketoprofen<br>* People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).<br>* Other names: Nonsteroidal anti-inflammatory drug;|
| Placebo Comparator: Cellulose<br>People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg). | Other: Cellulose<br>* People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).<br>* Other names: Placebo;Drug: Intravenous ketoprofen<br>* People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).<br>* Other names: Nonsteroidal anti-inflammatory drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Headache Severity. | The severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome | 2 hours | 
| Change in Headache Severity. | The severity of headache was assessed with visual numeric scale. Scale ranges: from zero (absence of pain) to 10 (maximum intensity of pain). Higher scores mean a worse outcome. | 2 hours | 
| Change in Headache Severity. | The severity of headache was assessed with faces pain scale. It is a self-reported pain scale consisting of face drawings which have a score ranging from zero (absence of pain) to five (maximal intensity of pain). Higher scores mean a worse outcome. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Levels of Biomarkers. | Evaluated biomarkers: neurotrophic factors and inflammatory mediators. | 2 hours | 

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