Ginger Capsules for the Acute Treatment of Migraine Attacks

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

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.

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Extract of ginger

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).

Group Type EXPERIMENTAL

Extract of ginger

Intervention Type DIETARY_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).

Intravenous ketoprofen

Intervention Type DRUG

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).

Cellulose

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).

Group Type PLACEBO_COMPARATOR

Cellulose

Intervention Type OTHER

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 ketoprofen

Intervention Type DRUG

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).

Interventions

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Extract of ginger

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).

Intervention Type DIETARY_SUPPLEMENT

Cellulose

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).

Intervention Type OTHER

Intravenous ketoprofen

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).

Intervention Type DRUG

Other Intervention Names

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Phytotherapy Placebo Nonsteroidal anti-inflammatory drug

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No