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The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.
Patients with the diagnosis of migraine according to the IHS criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extract of ginger | Experimental | Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks. |
|
| Cellulose | Placebo Comparator | Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extract of ginger | Other | Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the frequency of migraine attacks. | Frequency of migraine attacks will be assessed by headache diary. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in migraine impact in the last month. | Migraine impact will be assessed by HIT-6. | 4 weeks |
| Change in migraine impact in the last three months. | Migraine impact will be assessed by MIDAS. |
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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 |
| LaÃs B Martins, Ma | Federal University of Minas Gerais | Study Chair |
| Antônio L Teixeira, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatório Bias Fortes | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31398997 | Derived | Martins LB, Rodrigues AMDS, Monteze NM, Tibaes JRB, Amaral MHA, Gomez RS, Teixeira AL, Ferreira AVM. Double-blind placebo-controlled randomized clinical trial of ginger (Zingiber officinale Rosc.) in the prophylactic treatment of migraine. Cephalalgia. 2020 Jan;40(1):88-95. doi: 10.1177/0333102419869319. Epub 2019 Aug 9. |
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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 |
|---|---|
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Cellulose | Other | Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks. |
|
| 12 weeks |
| Changes in the serum levels of biomarkers. | Biomarkers: inflammatory mediators and neurotrophic factors | 12 weeks |
| Changes in Resting Energy Expenditure | Resting Energy Expenditure will be assessed by calorimeter | 4, 8 and 12 weeks |
| D009422 | Nervous System Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |