Ginger Capsules for the Acute Treatment of Migraine Attacks

Federal University of Minas Gerais60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine

Interventions

Extract of gingerDIETARY_SUPPLEMENT

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).

CelluloseOTHER

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).

Intravenous ketoprofenDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

* 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.

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 2 hours

Secondary Outcomes

Change in Serum Levels of Biomarkers.

Evaluated biomarkers: neurotrophic factors and inflammatory mediators.

Time frame: 2 hours

Data from ClinicalTrials.gov

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