Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-05 @ 5:41 PM
Study NCT ID:
NCT05221892
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018698', 'term': 'Glutamic Acid'}, {'id': 'C485829', 'term': 'calcium phosphate, dibasic, anhydrous'}, {'id': 'D013831', 'term': 'Thiamine'}, {'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'C000713927', 'term': 'ginger extract'}], 'ancestors': [{'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D018846', 'term': 'Excitatory Amino Acids'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-29', 'size': 274542, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2022-01-21T13:17', 'hasProtocol': True}, {'date': '2021-11-09', 'size': 110922, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-21T13:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'motion sickness assessment questionnaire', 'timeFrame': '1 year', 'description': 'The MSAQ consists of 16 questions, answered on a scale from one to nine points, which assesses the gastrointestinal, central and peripheral nervous system and soporous symptoms related to motion sickness.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vertigo', 'gamma aminobutyric acid', 'calcium', 'glutamic acid', 'thiamine', 'pyridoxine', 'cyanocobalamin', 'ginger'], 'conditions': ['Vertigo']}, 'referencesModule': {'references': [{'pmid': '25848702', 'type': 'BACKGROUND', 'citation': 'Marx W, Ried K, McCarthy AL, Vitetta L, Sali A, McKavanagh D, Isenring L. Ginger-Mechanism of action in chemotherapy-induced nausea and vomiting: A review. Crit Rev Food Sci Nutr. 2017 Jan 2;57(1):141-146. doi: 10.1080/10408398.2013.865590.'}, {'pmid': '11211039', 'type': 'BACKGROUND', 'citation': 'Gianaros PJ, Muth ER, Mordkoff JT, Levine ME, Stern RM. A questionnaire for the assessment of the multiple dimensions of motion sickness. Aviat Space Environ Med. 2001 Feb;72(2):115-9.'}, {'pmid': '9815340', 'type': 'BACKGROUND', 'citation': 'Schmid R, Schick T, Steffen R, Tschopp A, Wilk T. Comparison of Seven Commonly Used Agents for Prophylaxis of Seasickness. J Travel Med. 1994 Dec 1;1(4):203-206. doi: 10.1111/j.1708-8305.1994.tb00596.x.'}, {'pmid': '10518003', 'type': 'BACKGROUND', 'citation': 'Surh Y. Molecular mechanisms of chemopreventive effects of selected dietary and medicinal phenolic substances. Mutat Res. 1999 Jul 16;428(1-2):305-27. doi: 10.1016/s1383-5742(99)00057-5.'}, {'pmid': '17950516', 'type': 'BACKGROUND', 'citation': 'Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. Food Chem Toxicol. 2008 Feb;46(2):409-20. doi: 10.1016/j.fct.2007.09.085. Epub 2007 Sep 18.'}, {'pmid': '18564850', 'type': 'BACKGROUND', 'citation': 'Bailey-Shaw YA, Williams LA, Junor GA, Green CE, Hibbert SL, Salmon CN, Smith AM. Changes in the contents of oleoresin and pungent bioactive principles of Jamaican ginger (Zingiber officinale Roscoe.) during maturation. J Agric Food Chem. 2008 Jul 23;56(14):5564-71. doi: 10.1021/jf072782m. Epub 2008 Jun 20.'}, {'pmid': '31490017', 'type': 'BACKGROUND', 'citation': 'Calderon-Ospina CA, Nava-Mesa MO. B Vitamins in the nervous system: Current knowledge of the biochemical modes of action and synergies of thiamine, pyridoxine, and cobalamin. CNS Neurosci Ther. 2020 Jan;26(1):5-13. doi: 10.1111/cns.13207. Epub 2019 Sep 6.'}, {'pmid': '29253614', 'type': 'BACKGROUND', 'citation': 'Ezzat SM, Ezzat MI, Okba MM, Menze ET, Abdel-Naim AB. The hidden mechanism beyond ginger (Zingiber officinale Rosc.) potent in vivo and in vitro anti-inflammatory activity. J Ethnopharmacol. 2018 Mar 25;214:113-123. doi: 10.1016/j.jep.2017.12.019. Epub 2017 Dec 16.'}, {'type': 'BACKGROUND', 'citation': 'Zempleni J, Suttie JW, Gregory JF III, Stover PJ. Handbook of Vitamins. Boca Raton, Florida, USA: CRC Press; 2013.'}, {'pmid': '3537898', 'type': 'RESULT', 'citation': 'Grontved A, Hentzer E. Vertigo-reducing effect of ginger root. A controlled clinical study. ORL J Otorhinolaryngol Relat Spec. 1986;48(5):282-6. doi: 10.1159/000275883.'}, {'pmid': '10793599', 'type': 'RESULT', 'citation': 'Ernst E, Pittler MH. Efficacy of ginger for nausea and vomiting: a systematic review of randomized clinical trials. Br J Anaesth. 2000 Mar;84(3):367-71. doi: 10.1093/oxfordjournals.bja.a013442.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the efficacy and safety of a combination of aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine and cyanocobalamin as adjuvant therapy for vertigo comparatively to ginger under a double-blind randomized study design.', 'detailedDescription': 'Motion sickness is a chronic condition characterized by vestibular changes in response to stimuli caused either by movement or movement perception triggered by car, train, ship or aircraft transportation, amusement park rides, virtual reality and simulators, walking, exercising, as well as under the absence of gravity in space.The studied combination drug is composed by GABA (gamma-aminobutyric acid), the main inhibitory neurotransmitter of the central nervous system. The former lowers anxiety symptoms. Its precursor, glutamic acid, is the amino acid found in greater concentration under free form in the CNS; it is closely related to brain metabolism and, in contrast to GABA, it is the main excitatory neurotransmitter; glutamic acid also has anxyolytic therapeutic properties. Thiamine or vitamin B1 is a cofactor in the synthesis of acetylcholine, which plays a central role in the initiation and propagation of neural impulse in the CNS as well as it does in the skeletal and myocardial muscles. Pyridoxine or vitamin B6 plays a role in the synthesis of neurotransmitters such as dopamine as well as in the metabolism of tryptophan, resulting in an increase in serotonin so providing well-being and anxiety relief. Pyridoxine is essential for the proper functioning of the CNS (including at nausea and vomiting center). Cyancobalamin or Vitamin B12 plays a role in the growth and repair of nerve fibers. Importantly it also improves blood flow in the brain, with secondary vertigo improvement. The combined use of these substances provides relief of vertigo due to motion sickness. Zingiber officinale is a species of the Zingiberacaea family, widely used in traditional and herbal medicine for the treatment of various clinical conditions such as vertigo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical kinetosis\n* female study subjects must agree in using contraceptives during study period\n* dated informed consent read, understood and undersigned\n\nExclusion Criteria:\n\n* hypersensitivity to the drugs of the study\n* history of gallblader stones\n* history of gastric mucosa inflammation\n* arterial blood pressure \\>145/100 mmHg\n* use of medication for kinetosis other than the study drugs'}, 'identificationModule': {'nctId': 'NCT05221892', 'briefTitle': 'Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Fundação Educacional Serra dos Órgãos'}, 'officialTitle': 'Double Blind Evaluation of Gamma-aminobutyric Acid Tartarate 100 mg, Glutamic Acid 100 mg, Dibasic Calcium Phosphate 50 mg, Thiamine Nitrate 25 mg, Pyridoxine Chloride 10 mg and Cyanocobalamin 5 mcg Versus Ginger for Vertigo-kinetosis', 'orgStudyIdInfo': {'id': '50635421.30000.5247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test combination', 'description': 'Gamma-aminobutyric acid tartrate 100mg, glutamic acid 100mg, dibasic calcium phosphate 50mg, thiamine nitrate 25mg, pyridoxine hydrochloride 10mg and cyanocobalamin 5mcg', 'interventionNames': ['Drug: Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparative medication', 'description': 'Ginger extract 160mg (8mg gingerols)', 'interventionNames': ['Drug: Ginger']}], 'interventions': [{'name': 'Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin', 'type': 'DRUG', 'otherNames': ['Gamma-aminobutyric acid tartarate, and combinations'], 'description': 'Tablets to be taken 30 minutes before each of 4 trips.', 'armGroupLabels': ['Test combination']}, {'name': 'Ginger', 'type': 'DRUG', 'otherNames': ['Zingiber officinale'], 'description': 'Tablets to be taken 30 minutes before each of 4 trips.', 'armGroupLabels': ['Comparative medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25964004', 'city': 'Teresópolis', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Centro Universitário Serra dos Órgãos - UNIFESO', 'geoPoint': {'lat': -22.4167, 'lon': -42.97822}}], 'overallOfficials': [{'name': 'carlos p nunes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundação Educacional Serra dos Órgãos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundação Educacional Serra dos Órgãos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Carlos Pereira Nunes', 'investigatorAffiliation': 'Fundação Educacional Serra dos Órgãos'}}}}