MigraineNCT02570633
Ginger Capsules for the Prophylactic Treatment of Migraine
A study testing Extract of ginger and Cellulose in people with Migraine, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine. 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 and Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged between 18 and 60 years old;
- Migraine diagnosis;
- Agree to sign the informed consent.
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 other drugs;
- People with hypersensitivity to ginger compounds;
- People with severe neurological diseases (e.g. epilepsy)
- People in use of anticoagulant drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Extract of ginger, Cellulose
- Keywords
- Migraine, Ginger, Prophylactic 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 gingerOther
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.
CelluloseOther
Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Extract of ginger | Experimental | 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. Receives: Other: Extract of ginger |
| Cellulose | Placebo comparator | Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks. Receives: Other: Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of migraine attacks.
Frequency of migraine attacks will be assessed by headache diary.
Measured: 12 weeks
Secondary outcomes (4)
Change in migraine impact in the last month.
Migraine impact will be assessed by HIT-6.
Measured: 4 weeks
Change in migraine impact in the last three months.
Migraine impact will be assessed by MIDAS.
Measured: 12 weeks
Changes in the serum levels of biomarkers.
Biomarkers: inflammatory mediators and neurotrophic factors
Measured: 12 weeks
Changes in Resting Energy Expenditure
Resting Energy Expenditure will be assessed by calorimeter
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio L Teixeira Jr, Federal University of Minas Gerais
- Investigators
- Adaliene VM Ferreira, PhD, Study director, Federal University of Minas GeraisLaís B Martins, Ma, Study chair, Federal University of Minas GeraisAntônio L Teixeira, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570633
- Sponsor's protocol ID
- CAAE 28236814.3.0000.5149
- Status last verified
- Mar 2020
- First submitted
- 2 Oct 2015
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31398997
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 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) in Prophylactic Migraine Treatment
- ClinicalTrials.gov ID
- NCT02570633
- Acronym / sponsor ID
- CAAE 28236814.3.0000.5149
- Conditions
- Migraine
- Keywords
- Migraine, Ginger, Prophylactic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extract of ginger | Experimental | Other: Extract of gingerMigraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks. |
| Cellulose | Placebo comparator | Other: CelluloseMigraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 60 years old;
- Migraine diagnosis;
- Agree to sign the informed consent.
Key exclusion criteria (7 listed)
- 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;
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 gingerMigraine 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 |
| CelluloseMigraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks. | Other | Cellulose |
Primary outcome
Change in the frequency of migraine attacks.
Time frame: 12 weeks
Frequency of migraine attacks will be assessed by headache diary.
4 secondary outcomes
Change in migraine impact in the last month.
Time frame: 4 weeks
Change in migraine impact in the last three months.
Time frame: 12 weeks
Changes in the serum levels of biomarkers.
Time frame: 12 weeks
Changes in Resting Energy Expenditure
Time frame: 4, 8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Derived from this study: PubMed 31398997Martins 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extract of ginger and Cellulose in people with Migraine, run by Federal University of Minas Gerais at 1 site in Brazil.
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 7 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 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the frequency of migraine attacks. (time frame: 12 weeks). 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 NCT02570633, 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 16 Mar 2020.