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Completed

NCT Number: NCT02568644

Ginger Capsules for the Acute Treatment of Migraine Attacks

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Extract of ginger

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).

Other names: Phytotherapy

Cellulose

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).

Other names: Placebo

Intravenous ketoprofen

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).

Other names: Nonsteroidal anti-inflammatory drug

Primary outcomes

  1. Change in Headache Severity.

    Time frame: 2 hours

    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. Change in Headache Severity.

    Time frame: 2 hours

    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.

  3. Change in Headache Severity.

    Time frame: 2 hours

    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.

Secondary outcomes

  1. Change in Serum Levels of Biomarkers.

    Time frame: 2 hours

    Evaluated biomarkers: neurotrophic factors and inflammatory mediators.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 6, 2015
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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