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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Dietary Supplement: Extract of ginger
Other: Cellulose
Drug: Intravenous ketoprofen
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extract of Ginger Cellulose
Hide 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
Arm/Group Title Extract of Ginger Cellulose Total
Hide 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 Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
32.7  (8.8) 34.3  (9.1) 33.5  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Marital Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Single
17
  56.7%
15
  50.0%
32
  53.3%
Widowed/Divorced
1
   3.3%
2
   6.7%
3
   5.0%
Married
12
  40.0%
13
  43.3%
25
  41.7%
[1]
Measure Description:

Marital status was classified:

Married [n (%)] Single [n (%)] Widowed/Divorced [n (%)]

Occupation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Work
30
 100.0%
25
  83.3%
55
  91.7%
Do not work
0
   0.0%
5
  16.7%
5
   8.3%
[1]
Measure Description: Work [n (%)] Do not work [n (%)]
Migraine Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Migraine with aura
15
  50.0%
12
  40.0%
27
  45.0%
Migraine without aura
15
  50.0%
18
  60.0%
33
  55.0%
[1]
Measure Description: M. with aura [n (%)] M. without aura [n (%)]
Length of disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
11.0  (10.7) 10.0  (9.6) 10.5  (10.1)
Age of onset the disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
21.0  (9.8) 23.1  (9.4) 22.7  (9.6)
Number of migraine attacks/month  
Mean (Standard Deviation)
Unit of measure:  Migraine attacks/month
Number Analyzed 30 participants 30 participants 60 participants
2.2  (1.3) 2.7  (1.2) 2.4  (1.2)
Migraine Disability Test (MIDAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
17.4  (14.2) 14.2  (8.3) 15.8  (11.2)
[1]
Measure Description:

Migraine Disability Test (MIDAS)

The MIDAS is a questionnaire designed to quantify headache-related disability over a 3 month period.

Total Score is obtained with the sum of days lost in social, domestic and work activities

The total score corresponding to four categories:

0 to 5 = Grade I - Llittle or no disability 6 to 10 = Grade II - Mild disability 11 to 20 = Grade III - Moderate disability 21 or + = Grade IV - Severe disability

Headache Impact Test, version 6 (HIT-6)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
64.6  (5.5) 66.9  (4.2) 65.7  (4.8)
[1]
Measure Description:

Headache Impact Test, version 6 (HIT-6)

HIT-6 measures the disability caused by headaches in the previous month. This questionnaire consists of six questions whose answer alternatives are given in frequency. The result is the sum of the points for each answer.

The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).

BDI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
11.2  (6.8) 13.9  (9.3) 12.5  (8.0)
[1]
Measure Description:

Beck Depression Inventory

The BDI measures the severity of depressive episodes. It is a self-report questionnaire with 21 groups of statements that express levels of severity of depressive symptoms ranging from 0 to 3 points.

The standard cut-off scores are as follows:

0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-+: indicates severe depression.

Pain intensity (Four-point Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
2.46  (0.09) 2.56  (0.09) 2.51  (0.09)
[1]
Measure Description: The 4-point verbal scale consists of pain classification in scores between zero and three that correspond to: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain
Pain intensity (Faces Pain Scale)  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
2.90  (0.17) 2.96  (0.17) 2.93  (0.17)
Pain intensity (Visual Numeric Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
7.03  (0.26) 7.63  (0.25) 7.33  (0.25)
[1]
Measure Description: The numerical visual scale has a score ranging from zero to 10 and is associated with the description of pain intensity and functional capacity, where zero corresponds to absence of pain and ten to maximum, disabling pain.
1.Primary Outcome
Title Change in Headache Severity.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extract of Ginger Cellulose
Hide 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).

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.81  (0.04) 0.97  (0.07)
2.Primary Outcome
Title Change in Headache Severity.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extract of Ginger Cellulose
Hide 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).

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.03  (0.29) 2.30  (0.46)
3.Primary Outcome
Title Change in Headache Severity.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extract of Ginger Cellulose
Hide 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).

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.43  (0.13) 0.90  (0.18)
4.Secondary Outcome
Title Change in Serum Levels of Biomarkers.
Hide Description Evaluated biomarkers: neurotrophic factors and inflammatory mediators.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Brain derived neurotrophic factor - BDNF (pg/mL)
Arm/Group Title Extract of Ginger Cellulose
Hide 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).

Overall Number of Participants Analyzed 30 30
Median (95% Confidence Interval)
Unit of Measure: BDNF (pg/mL)
6077
(5694 to 6944)
6503
(5929 to 7244)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extract of Ginger Cellulose
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Extract of Ginger Cellulose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extract of Ginger Cellulose
Affected / at Risk (%) Affected / at Risk (%)
Total   3/30 (10.00%)   3/30 (10.00%) 
Gastrointestinal disorders     
Dyspepsia *  3/30 (10.00%)  0/30 (0.00%) 
Dizziness *  0/30 (0.00%)  1/30 (3.33%) 
Nausea *  0/30 (0.00%)  2/30 (6.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Antonio Lucio Teixeira
Organization: Universidade Federal de Minas Gerias
EMail: altexr@gmail.com
Layout table for additonal information
Responsible Party: Antonio L Teixeira Jr, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02568644    
Other Study ID Numbers: CAAE 21057913.9.0000.5135
First Submitted: October 2, 2015
First Posted: October 6, 2015
Results First Submitted: March 13, 2020
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020