Ginger Capsules for the Prophylactic Treatment of Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Other: Cellulose; Other: Extract of ginger

• Registration Number: NCT02570633
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Primary Completion: 2016-07
• Study Completion: 2016-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in the frequency of migraine attacks.	12 weeks	Frequency of migraine attacks will be assessed by headache diary.

Secondary Outcome Measures

Name	Time	Method
Change in migraine impact in the last month.	4 weeks	Migraine impact will be assessed by HIT-6.
Change in migraine impact in the last three months.	12 weeks	Migraine impact will be assessed by MIDAS.
Changes in the serum levels of biomarkers.	12 weeks	Biomarkers: inflammatory mediators and neurotrophic factors
Changes in Resting Energy Expenditure	4, 8 and 12 weeks	Resting Energy Expenditure will be assessed by calorimeter

Trial Locations

Locations (1)

Ambulatório Bias Fortes; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil