Ginger Capsules for the Acute Treatment of Migraine Attacks

Federal University of Minas Gerais

Status: Completed

Conditions: Migraine

Treatments: Dietary Supplement: Extract of ginger; Other: Cellulose; Drug: Intravenous ketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02568644

CAAE 21057913.9.0000.5135

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Extract of ginger

Experimental group

Description:

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).

Treatment:

Drug: Intravenous ketoprofen

Dietary Supplement: Extract of ginger

Cellulose

Placebo Comparator group

Description:

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).

Treatment:

Drug: Intravenous ketoprofen

Other: Cellulose