Ginger Capsules for the Acute Treatment of Migraine Attacks
Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedApril 7, 2020
March 1, 2020
3 months
October 2, 2015
March 13, 2020
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
2 hours
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.
2 hours
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.
2 hours
Secondary Outcomes (1)
Change in Serum Levels of Biomarkers.
2 hours
Study Arms (2)
Extract of ginger
EXPERIMENTALPeople (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).
Cellulose
PLACEBO COMPARATORPeople (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).
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- Migraine diagnosis for at least one year;
- Migraine attack with moderate or severe pain intensity;
- One to six migraine attacks per month.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29768938DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Antonio Lucio Teixeira
- Organization
- Universidade Federal de Minas Gerias
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 6, 2015
Study Start
July 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 7, 2020
Results First Posted
April 7, 2020
Record last verified: 2020-03