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Ginger Capsules for the Prophylactic Treatment of Migraine

This study is currently recruiting participants.
Verified March 2016 by Antonio L Teixeira Jr, Federal University of Minas Gerais
Sponsor:
ClinicalTrials.gov Identifier:
NCT02570633
First Posted: October 7, 2015
Last Update Posted: March 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Antonio L Teixeira Jr, Federal University of Minas Gerais
  Purpose
The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

Condition Intervention
Migraine Other: Extract of ginger Other: Cellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment

Resource links provided by NLM:


Further study details as provided by Antonio L Teixeira Jr, Federal University of Minas Gerais:

Primary Outcome Measures:
  • Change in the frequency of migraine attacks. [ Time Frame: 12 weeks ]
    Frequency of migraine attacks will be assessed by headache diary.


Secondary Outcome Measures:
  • Change in migraine impact in the last month. [ Time Frame: 4 weeks ]
    Migraine impact will be assessed by HIT-6.

  • Change in migraine impact in the last three months. [ Time Frame: 12 weeks ]
    Migraine impact will be assessed by MIDAS.

  • Changes in the serum levels of biomarkers. [ Time Frame: 12 weeks ]
    Biomarkers: inflammatory mediators, neurotrophic factors, oxidative stress markers.


Estimated Enrollment: 104
Study Start Date: July 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extract of ginger
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.
Other: Extract of ginger
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.
Placebo Comparator: Cellulose
Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
Other: Cellulose
Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570633


Contacts
Contact: Antônio L Teixeira, PhD +553134098073 altexr@gmail.com

Locations
Brazil
Ambulatório Bias Fortes Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Contact: Antônio L Teixeira, PhD    3134098073    altexr@gmail.com   
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Study Director: Adaliene VM Ferreira, PhD Federal University of Minas Gerais
Study Chair: Laís B Martins, Ma Federal University of Minas Gerais
Principal Investigator: Antônio L Teixeira, PhD Federal University of Minas Gerais
  More Information

Responsible Party: Antonio L Teixeira Jr, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02570633     History of Changes
Other Study ID Numbers: CAAE 28236814.3.0000.5149
First Submitted: October 2, 2015
First Posted: October 7, 2015
Last Update Posted: March 25, 2016
Last Verified: March 2016

Keywords provided by Antonio L Teixeira Jr, Federal University of Minas Gerais:
Migraine
Ginger
Prophylactic treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases