Ginger Capsules for the Acute Treatment of Migraine Attacks

Migraine Clinical Trial

Official title:

Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568644
• Other study ID #: CAAE 21057913.9.0000.5135
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: October 2014

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 was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.

Description:

Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

• Inclusion Criteria:

• Migraine diagnosis for at least one year;

• Migraine attack with moderate or severe pain intensity;

• One to six migraine attacks per month.

• 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 drugs;

• People with hypersensitivity to ginger;

• People with other neurological diseases;

• People in use of anticoagulant drugs;

• People who have started the disease after 50 years old.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• Extract of ginger
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).

Other:
• Cellulose
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).

Drug:
• Intravenous ketoprofen
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Headache Severity.	The severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome	2 hours
Primary	Change in Headache Severity.	The severity of headache was assessed with visual numeric scale. Scale ranges: from zero (absence of pain) to 10 (maximum intensity of pain). Higher scores mean a worse outcome.	2 hours
Primary	Change in Headache Severity.	The severity of headache was assessed with faces pain scale. It is a self-reported pain scale consisting of face drawings which have a score ranging from zero (absence of pain) to five (maximal intensity of pain).; Higher scores mean a worse outcome.	2 hours
Secondary	Change in Serum Levels of Biomarkers.	Evaluated biomarkers: neurotrophic factors and inflammatory mediators.	2 hours