Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ginger Capsules for the Acute Treatment of Migraine Attacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568644
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio L Teixeira Jr, 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.

Condition or disease Intervention/treatment Phase
Migraine Dietary Supplement: Extract of ginger Other: Cellulose Drug: Intravenous ketoprofen Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: 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).
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 Name: Phytotherapy

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).
Other Name: Nonsteroidal anti-inflammatory drug

Placebo Comparator: 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).
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).
Other Name: Placebo

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).
Other Name: Nonsteroidal anti-inflammatory drug




Primary Outcome Measures :
  1. Change in Headache Severity. [ Time Frame: 2 hours ]
    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. Change in Headache Severity. [ Time Frame: 2 hours ]
    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.

  3. Change in Headache Severity. [ Time Frame: 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 :
  1. Change in Serum Levels of Biomarkers. [ Time Frame: 2 hours ]
    Evaluated biomarkers: neurotrophic factors and inflammatory mediators.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568644


Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Layout table for investigator information
Study Director: Adaliene VM Ferreira, PhD Federal University of Minas Gerais
Study Chair: Laís B Martins, Ma Federal University of Minas Gerais
Principal Investigator: Antônio L Teixeira, PhD Federal University of Minas Gerais
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Antonio L Teixeira Jr, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02568644    
Other Study ID Numbers: CAAE 21057913.9.0000.5135
First Posted: October 6, 2015    Key Record Dates
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020
Last Verified: March 2020
Keywords provided by Antonio L Teixeira Jr, Federal University of Minas Gerais:
Migraine
Ginger
Acute treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action