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Completed

NCT Number: NCT02570633

Ginger Capsules for the Prophylactic Treatment of Migraine

The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

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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

Primary location

Ambulatório Bias Fortes

Belo Horizonte, Minas Gerais, 30130-100, Brazil

About this study

Patients with the diagnosis of migraine according to the IHS criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 18 and 60 years old;
  • Migraine diagnosis;
  • Agree to sign the informed consent.

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 other drugs;
  • People with hypersensitivity to ginger compounds;
  • People with severe neurological diseases (e.g. epilepsy)
  • People in use of anticoagulant drugs.

Treatment and study plan

Extract of ginger

Other

Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks.

Cellulose

Other

Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.

Primary outcomes

  1. Change in the frequency of migraine attacks.

    Time frame: 12 weeks

    Frequency of migraine attacks will be assessed by headache diary.

Secondary outcomes

  1. Change in migraine impact in the last month.

    Time frame: 4 weeks

    Migraine impact will be assessed by HIT-6.

  2. Change in migraine impact in the last three months.

    Time frame: 12 weeks

    Migraine impact will be assessed by MIDAS.

  3. Changes in the serum levels of biomarkers.

    Time frame: 12 weeks

    Biomarkers: inflammatory mediators and neurotrophic factors

  4. Changes in Resting Energy Expenditure

    Time frame: 4, 8 and 12 weeks

    Resting Energy Expenditure will be assessed by calorimeter

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) in Prophylactic Migraine Treatment

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Mar 16, 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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