Ginger Capsules for the Prophylactic Treatment of Migraine

Migraine Clinical Trial

Official title:

Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570633
• Other study ID #: CAAE 28236814.3.0000.5149
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

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