Ginger Capsules for the Prophylactic Treatment of Migraine

March 12, 2020 updated by: Antonio L Teixeira Jr, Federal University of Minas Gerais

Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Ambulatório Bias Fortes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the frequency of migraine attacks.
Time Frame: 12 weeks
Frequency of migraine attacks will be assessed by headache diary.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in migraine impact in the last month.
Time Frame: 4 weeks
Migraine impact will be assessed by HIT-6.
4 weeks
Change in migraine impact in the last three months.
Time Frame: 12 weeks
Migraine impact will be assessed by MIDAS.
12 weeks
Changes in the serum levels of biomarkers.
Time Frame: 12 weeks
Biomarkers: inflammatory mediators and neurotrophic factors
12 weeks
Changes in Resting Energy Expenditure
Time Frame: 4, 8 and 12 weeks
Resting Energy Expenditure will be assessed by calorimeter
4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 28236814.3.0000.5149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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