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Ginger Capsules for the Prophylactic Treatment of Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Extract of ginger
Cellulose
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Migraine, Ginger, Prophylactic treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ambulatório Bias Fortes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Extract of ginger

Cellulose

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in the frequency of migraine attacks.
Frequency of migraine attacks will be assessed by headache diary.

Secondary Outcome Measures

Change in migraine impact in the last month.
Migraine impact will be assessed by HIT-6.
Change in migraine impact in the last three months.
Migraine impact will be assessed by MIDAS.
Changes in the serum levels of biomarkers.
Biomarkers: inflammatory mediators and neurotrophic factors
Changes in Resting Energy Expenditure
Resting Energy Expenditure will be assessed by calorimeter

Full Information

First Posted
October 2, 2015
Last Updated
March 12, 2020
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02570633
Brief Title
Ginger Capsules for the Prophylactic Treatment of Migraine
Official Title
Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Ginger, Prophylactic treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extract of ginger
Arm Type
Experimental
Arm Description
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.
Arm Title
Cellulose
Arm Type
Placebo Comparator
Arm Description
Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Extract of ginger
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cellulose
Intervention Description
Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
Primary Outcome Measure Information:
Title
Change in the frequency of migraine attacks.
Description
Frequency of migraine attacks will be assessed by headache diary.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in migraine impact in the last month.
Description
Migraine impact will be assessed by HIT-6.
Time Frame
4 weeks
Title
Change in migraine impact in the last three months.
Description
Migraine impact will be assessed by MIDAS.
Time Frame
12 weeks
Title
Changes in the serum levels of biomarkers.
Description
Biomarkers: inflammatory mediators and neurotrophic factors
Time Frame
12 weeks
Title
Changes in Resting Energy Expenditure
Description
Resting Energy Expenditure will be assessed by calorimeter
Time Frame
4, 8 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adaliene VM Ferreira, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laís B Martins, Ma
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antônio L Teixeira, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatório Bias Fortes
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31398997
Citation
Martins LB, Rodrigues AMDS, Monteze NM, Tibaes JRB, Amaral MHA, Gomez RS, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger (Zingiber officinale Rosc.) in the prophylactic treatment of migraine. Cephalalgia. 2020 Jan;40(1):88-95. doi: 10.1177/0333102419869319. Epub 2019 Aug 9.
Results Reference
derived

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Ginger Capsules for the Prophylactic Treatment of Migraine

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