Ginger Capsules for the Acute Treatment of Migraine Attacks

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Dietary Supplement: Extract of ginger; Other: Cellulose; Drug: Intravenous ketoprofen

• Registration Number: NCT02568644
• Lead Sponsor: Federal University of Minas Gerais

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Status Verified: 2020-03
• Results First Submitted: 2020-03-13
• Results First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Results First Posted: 2020-04-07
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extract of ginger	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) and intravenous ketoprofen (100mg).
Extract of ginger	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 two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg).
Cellulose	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) and intravenous ketoprofen (100mg).
Cellulose	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 two placebo capsules (cellulose) and intravenous ketoprofen (100mg).

Primary Outcome Measures

Name	Time	Method
Change in Headache Severity.	2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Levels of Biomarkers.	2 hours	Evaluated biomarkers: neurotrophic factors and inflammatory mediators.