Ginger Capsules for the Acute Treatment of Migraine Attacks

• Sponsor: Federal University of Minas Gerais (Other)
• Overall Status: Completed
• CT.gov ID: NCT02568644
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: Nonsteroidal anti-inflammatory drug

Outcome Measures

Primary Outcome Measures

1. Change in Headache Severity. [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. [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. [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. [2 hours]

   Evaluated biomarkers: neurotrophic factors and inflammatory mediators.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of Minas Gerais

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 6, 2015
• Last Update Posted: Apr 7, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Antonio L Teixeira Jr, PhD, Federal University of Minas Gerais: Migraine; Ginger; Acute treatment
• Additional relevant MeSH terms: Migraine Disorders; Ketoprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents

Study Results

Participant Flow

Arm/Group Title	Extract of Ginger	Cellulose
Arm/Group Description	30 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 gingerois) and intravenous ketoprofen (100mg). Extract of ginger: 30 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 gingerois). Intravenous ketoprofen: 30 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).	30 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: 30 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). Intravenous ketoprofen: 30 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).
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Extract of Ginger	Cellulose	Total
Arm/Group Description	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: 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). 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).	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: 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). 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).	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.7 (8.8)	34.3 (9.1)	33.5 (8.9)
Sex: Female, Male (Count of Participants)
Female	26 86.7%	26 86.7%	52 86.7%
Male	4 13.3%	4 13.3%	8 13.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Marital Status (Count of Participants)
Single	17 56.7%	15 50%	32 53.3%
Widowed/Divorced	1 3.3%	2 6.7%	3 5%
Married	12 40%	13 43.3%	25 41.7%
Occupation (Count of Participants)
Work	30 100%	25 83.3%	55 91.7%
Do not work	0 0%	5 16.7%	5 8.3%
Migraine Diagnosis (Count of Participants)
Migraine with aura	15 50%	12 40%	27 45%
Migraine without aura	15 50%	18 60%	33 55%
Length of disease (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.0 (10.7)	10.0 (9.6)	10.5 (10.1)
Age of onset the disease (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.0 (9.8)	23.1 (9.4)	22.7 (9.6)
Number of migraine attacks/month (migraine attacks/month) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [migraine attacks/month]	2.2 (1.3)	2.7 (1.2)	2.4 (1.2)
Migraine Disability Test (MIDAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.4 (14.2)	14.2 (8.3)	15.8 (11.2)
Headache Impact Test, version 6 (HIT-6) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	64.6 (5.5)	66.9 (4.2)	65.7 (4.8)
BDI (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.2 (6.8)	13.9 (9.3)	12.5 (8.0)
Pain intensity (Four-point Scale) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.46 (0.09)	2.56 (0.09)	2.51 (0.09)
Pain intensity (Faces Pain Scale) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.90 (0.17)	2.96 (0.17)	2.93 (0.17)
Pain intensity (Visual Numeric Scale) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.03 (0.26)	7.63 (0.25)	7.33 (0.25)

Outcome Measures

1. Primary Outcome

Title	Change in Headache Severity.
Description	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
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extract of Ginger	Cellulose
Arm/Group Description	30 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 gingerois) and intravenous ketoprofen (100mg). Extract of ginger: 30 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 gingerois). Intravenous ketoprofen: 30 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).	30 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: 30 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). Intravenous ketoprofen: 30 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).
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	0.81 (0.04)	0.97 (0.07)

2. Primary Outcome

Title	Change in Headache Severity.
Description	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.
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extract of Ginger	Cellulose
Arm/Group Description	30 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 gingerois) and intravenous ketoprofen (100mg). Extract of ginger: 30 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 gingerois). Intravenous ketoprofen: 30 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).	30 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: 30 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). Intravenous ketoprofen: 30 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).
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	1.03 (0.29)	2.30 (0.46)

3. Primary Outcome

Title	Change in Headache Severity.
Description	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.
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extract of Ginger	Cellulose
Arm/Group Description	30 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 gingerois) and intravenous ketoprofen (100mg). Extract of ginger: 30 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 gingerois). Intravenous ketoprofen: 30 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).	30 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: 30 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). Intravenous ketoprofen: 30 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).
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	0.43 (0.13)	0.90 (0.18)

4. Secondary Outcome

Title	Change in Serum Levels of Biomarkers.
Description	Evaluated biomarkers: neurotrophic factors and inflammatory mediators.
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

Brain derived neurotrophic factor - BDNF (pg/mL)

Arm/Group Title	Extract of Ginger	Cellulose
Arm/Group Description	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 gingerois) and intravenous ketoprofen (100mg). 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 gingerois). 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).	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: 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). 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).
Measure Participants	30	30
Median (95% Confidence Interval) [BDNF (pg/mL)]	6077	6503

Adverse Events

Arm/Group Title	Extract of Ginger		Cellulose
Arm/Group Description	30 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 gingerois) and intravenous ketoprofen (100mg). Extract of ginger: 30 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 gingerois). Intravenous ketoprofen: 30 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).		30 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: 30 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). Intravenous ketoprofen: 30 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).
All Cause Mortality
	Extract of Ginger		Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Extract of Ginger		Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Extract of Ginger		Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/30 (10%)		3/30 (10%)
Gastrointestinal disorders
Dyspepsia	3/30 (10%)		0/30 (0%)
Dizziness	0/30 (0%)		1/30 (3.3%)
Nausea	0/30 (0%)		2/30 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.