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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extract of ginger | Experimental | 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 | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extract of ginger | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Levels of Biomarkers. | Evaluated biomarkers: neurotrophic factors and inflammatory mediators. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adaliene VM Ferreira, PhD | Federal University of Minas Gerais | Study Director |
| Laís B Martins, Ma | Federal University of Minas Gerais | Study Chair |
| Antônio L Teixeira, PhD | Federal University of Minas Gerais | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29768938 | Derived | Martins LB, Rodrigues AMDS, Rodrigues DF, Dos Santos LC, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger ( Zingiber officinale Rosc.) addition in migraine acute treatment. Cephalalgia. 2019 Jan;39(1):68-76. doi: 10.1177/0333102418776016. Epub 2018 May 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) 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). |
| FG001 | 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) 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antonio Lucio Teixeira | Universidade Federal de Minas Gerias | altexr@gmail.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008517 | Phytotherapy |
| D002482 | Cellulose |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D005936 | Glucans |
| D001704 | Biopolymers |
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|
| Cellulose | Other | 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 | Drug | 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). |
|
|
| BG001 | 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: 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Marital Status | Marital status was classified: Married [n (%)] Single [n (%)] Widowed/Divorced [n (%)] | Count of Participants | Participants |
|
| Occupation | Work [n (%)] Do not work [n (%)] | Count of Participants | Participants |
|
| Migraine Diagnosis | M. with aura [n (%)] M. without aura [n (%)] | Count of Participants | Participants |
|
| Length of disease | Mean | Standard Deviation | years |
|
| Age of onset the disease | Mean | Standard Deviation | years |
|
| Number of migraine attacks/month | Mean | Standard Deviation | migraine attacks/month |
|
| Migraine Disability Test (MIDAS) | 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 | Mean | Standard Deviation | units on a scale |
|
| Headache Impact Test, version 6 (HIT-6) | 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). | Mean | Standard Deviation | units on a scale |
|
| BDI | 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. | Mean | Standard Deviation | units on a scale |
|
| Pain intensity (Four-point Scale) | 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 | Mean | Standard Deviation | units on a scale |
|
| Pain intensity (Faces Pain Scale) | Mean | Standard Deviation | units on a scale |
|
| Pain intensity (Visual Numeric Scale) | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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) 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). |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
|
|
| Secondary | Change in Serum Levels of Biomarkers. | Evaluated biomarkers: neurotrophic factors and inflammatory mediators. | Brain derived neurotrophic factor - BDNF (pg/mL) | Posted | Median | 95% Confidence Interval | BDNF (pg/mL) | 2 hours |
|
|
|
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | 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) 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). | 0 | 30 | 3 | 30 |
| Dizziness | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| Married |
|