Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02570633
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2015-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ginger Capsules for the Prophylactic Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002482', 'term': 'Cellulose'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2015-10-02', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the frequency of migraine attacks.', 'timeFrame': '12 weeks', 'description': 'Frequency of migraine attacks will be assessed by headache diary.'}], 'secondaryOutcomes': [{'measure': 'Change in migraine impact in the last month.', 'timeFrame': '4 weeks', 'description': 'Migraine impact will be assessed by HIT-6.'}, {'measure': 'Change in migraine impact in the last three months.', 'timeFrame': '12 weeks', 'description': 'Migraine impact will be assessed by MIDAS.'}, {'measure': 'Changes in the serum levels of biomarkers.', 'timeFrame': '12 weeks', 'description': 'Biomarkers: inflammatory mediators and neurotrophic factors'}, {'measure': 'Changes in Resting Energy Expenditure', 'timeFrame': '4, 8 and 12 weeks', 'description': 'Resting Energy Expenditure will be assessed by calorimeter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Migraine', 'Ginger', 'Prophylactic treatment'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '31398997', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 60 years old;\n* Migraine diagnosis;\n* Agree to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with headaches not characterized as migraine;\n* Pregnant or lactating women;\n* Fertile and sexually active women who do not use contraception;\n* Abuse of painkillers, alcohol or other drugs;\n* People with hypersensitivity to ginger compounds;\n* People with severe neurological diseases (e.g. epilepsy)\n* People in use of anticoagulant drugs.'}, 'identificationModule': {'nctId': 'NCT02570633', 'briefTitle': 'Ginger Capsules for the Prophylactic Treatment of Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment', 'orgStudyIdInfo': {'id': 'CAAE 28236814.3.0000.5149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extract of ginger', 'description': '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.', 'interventionNames': ['Other: Extract of ginger']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cellulose', 'description': 'Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.', 'interventionNames': ['Other: Cellulose']}], 'interventions': [{'name': 'Extract of ginger', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Extract of ginger']}, {'name': 'Cellulose', 'type': 'OTHER', 'description': 'Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.', 'armGroupLabels': ['Cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Ambulatório Bias Fortes', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'overallOfficials': [{'name': 'Adaliene VM Ferreira, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Minas Gerais'}, {'name': 'Laís B Martins, Ma', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Minas Gerais'}, {'name': 'Antônio L Teixeira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Antonio L Teixeira Jr', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}