Ginger Capsules for the Prophylactic Treatment of Migraine

NCT ID: NCT02570633

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Extract of ginger

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.

Group Type EXPERIMENTAL

Extract of ginger

Intervention Type OTHER

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.

Cellulose

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

Group Type PLACEBO_COMPARATOR

Cellulose

Intervention Type OTHER

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

Interventions

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Extract of ginger

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

Cellulose

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Antonio L Teixeira Jr

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adaliene VM Ferreira, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Laís B Martins, Ma

Role: STUDY_CHAIR

Federal University of Minas Gerais

Antônio L Teixeira, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Ambulatório Bias Fortes

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 31398997 (View on PubMed)

Other Identifiers

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CAAE 28236814.3.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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