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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02570633
Other study ID # CAAE 28236814.3.0000.5149
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date November 2016

Study information

Verified date March 2020
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date November 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Ambulatório Bias Fortes Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the frequency of migraine attacks. Frequency of migraine attacks will be assessed by headache diary. 12 weeks
Secondary Change in migraine impact in the last month. Migraine impact will be assessed by HIT-6. 4 weeks
Secondary Change in migraine impact in the last three months. Migraine impact will be assessed by MIDAS. 12 weeks
Secondary Changes in the serum levels of biomarkers. Biomarkers: inflammatory mediators and neurotrophic factors 12 weeks
Secondary Changes in Resting Energy Expenditure Resting Energy Expenditure will be assessed by calorimeter 4, 8 and 12 weeks
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