MigraineNCT02568644

Ginger Capsules for the Acute Treatment of Migraine Attacks

A study testing Extract of ginger, Cellulose and Intravenous ketoprofen in people with Migraine, run by Federal University of Minas Gerais.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Migraine
What is being tested?: Extract of ginger, Cellulose and Intravenous ketoprofen
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Jul 2014to Oct 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Migraine diagnosis for at least one year;
Migraine attack with moderate or severe pain intensity;
One to six migraine attacks per month.

Who cannot join

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.

About this study

Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks

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.

Read the 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.

Conditions: Migraine
Being tested: Extract of ginger, Cellulose, Intravenous ketoprofen
Keywords: Migraine, Ginger, Acute treatment
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extract of gingerDietary supplement
Also called Phytotherapy
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).
CelluloseOther
Also called Placebo
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).
Intravenous ketoprofenDrug
Also called Nonsteroidal anti-inflammatory drug
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).

Study groups in NCT02568644
Study group	Role	What they receive
Extract of ginger	Experimental	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). Receives: Dietary Supplement: Extract of ginger; Drug: Intravenous ketoprofen
Cellulose	Placebo comparator	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). Receives: Other: Cellulose; Drug: Intravenous ketoprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 2 hours

Secondary outcomes (1)

Change in Serum Levels of Biomarkers.
Evaluated biomarkers: neurotrophic factors and inflammatory mediators.
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2014

First posted6 Oct 2015 (estimated)
Study startJul 2014
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02568644
Sponsor's protocol ID: CAAE 21057913.9.0000.5135
Status last verified: Mar 2020
First submitted: 2 Oct 2015
Last updated: 7 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 29768938

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Marine Lipids Ease Painful TMD
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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks
ClinicalTrials.gov ID: NCT02568644
Acronym / sponsor ID: CAAE 21057913.9.0000.5135
Conditions: Migraine
Keywords: Migraine, Ginger, Acute treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Federal University of Minas GeraisUniversity, hospital or other
Study start: Jul 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 6 Oct 2015 (estimated)
Results: Posted 7 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Extract of ginger	Experimental	Dietary Supplement: Extract of ginger, Drug: Intravenous ketoprofenPeople (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 comparator	Other: Cellulose, Drug: Intravenous ketoprofenPeople (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).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Key exclusion criteria (8 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extract of gingerAlso: PhytotherapyPeople (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).	Dietary supplement	Extract of ginger
CelluloseAlso: PlaceboPeople (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).	Other	Cellulose
Intravenous ketoprofenAlso: Nonsteroidal anti-inflammatory drugPeople (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).	Drug	Cellulose, Extract of ginger

Primary outcome

Change in Headache Severity.
Time frame: 2 hours
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.
Time frame: 2 hours
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.
Time frame: 2 hours
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.

1 secondary outcome

Change in Serum Levels of Biomarkers.
Time frame: 2 hours

Results and safety

Results posted to the registry on 7 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Extract of Ginger	30	30
Cellulose	30	30

Primary outcome: Change in Headache Severity.

Time frame: 2 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Extract of Ginger n = 30	Cellulose n = 30
Value	0.81 (0.04)	0.97 (0.07)

Primary outcome: Change in Headache Severity.

Time frame: 2 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Extract of Ginger n = 30	Cellulose n = 30
Value	1.03 (0.29)	2.30 (0.46)

Primary outcome: Change in Headache Severity.

Time frame: 2 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Extract of Ginger n = 30	Cellulose n = 30
Value	0.43 (0.13)	0.90 (0.18)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extract of Ginger	0 of 30 (0%)	3 of 30 (10%)	Not reported
Cellulose	0 of 30 (0%)	3 of 30 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29768938Martins 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.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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Recruiting
Marine Lipids Ease Painful TMD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adaliene VM Ferreira, PhD study director

Federal University of Minas Gerais

Laís B Martins, Ma study chair

Federal University of Minas Gerais

Antônio L Teixeira, PhD principal investigator

Federal University of Minas Gerais

Questions about this trial

What is this clinical trial studying?

A study testing Extract of ginger, Cellulose and Intravenous ketoprofen in people with Migraine, run by Federal University of Minas Gerais.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Headache Severity. (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02568644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.