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Ginger Capsules for the Acute Treatment of Migraine Attacks

Primary Purpose

Migraine

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

About this trial

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

Eligibility Criteria

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

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Extract of ginger

    Cellulose

    Arm Description

    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) and intravenous ketoprofen (100mg).

    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) and intravenous ketoprofen (100mg).

    Outcomes

    Primary Outcome Measures

    Change in Headache Severity.
    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
    Change in Headache Severity.
    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.
    Change in Headache Severity.
    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 Outcome Measures

    Change in Serum Levels of Biomarkers.
    Evaluated biomarkers: neurotrophic factors and inflammatory mediators.

    Full Information

    First Posted
    October 2, 2015
    Last Updated
    March 26, 2020
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02568644
    Brief Title
    Ginger Capsules for the Acute Treatment of Migraine Attacks
    Official Title
    Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (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 was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.
    Detailed Description
    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.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Extract of ginger
    Arm Type
    Experimental
    Arm Description
    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) and intravenous ketoprofen (100mg).
    Arm Title
    Cellulose
    Arm Type
    Placebo Comparator
    Arm Description
    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) and intravenous ketoprofen (100mg).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Extract of ginger
    Other Intervention Name(s)
    Phytotherapy
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Cellulose
    Other Intervention Name(s)
    Placebo
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous ketoprofen
    Other Intervention Name(s)
    Nonsteroidal anti-inflammatory drug
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change in Headache Severity.
    Description
    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
    Time Frame
    2 hours
    Title
    Change in Headache Severity.
    Description
    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.
    Time Frame
    2 hours
    Title
    Change in Headache Severity.
    Description
    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.
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Change in Serum Levels of Biomarkers.
    Description
    Evaluated biomarkers: neurotrophic factors and inflammatory mediators.
    Time Frame
    2 hours

    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: 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.
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29768938
    Citation
    Martins LB, Rodrigues AMDS, Rodrigues DF, Dos Santos LC, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger ( Zingiber officinale Rosc.) addition in migraine acute treatment. Cephalalgia. 2019 Jan;39(1):68-76. doi: 10.1177/0333102418776016. Epub 2018 May 16.
    Results Reference
    derived

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    Ginger Capsules for the Acute Treatment of Migraine Attacks

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