Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo
Primary Purpose
Vertigo
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin
Ginger
Sponsored by
About this trial
This is an interventional treatment trial for Vertigo focused on measuring vertigo, gamma aminobutyric acid, calcium, glutamic acid, thiamine, pyridoxine, cyanocobalamin, ginger
Eligibility Criteria
Inclusion Criteria:
- clinical kinetosis
- female study subjects must agree in using contraceptives during study period
- dated informed consent read, understood and undersigned
Exclusion Criteria:
- hypersensitivity to the drugs of the study
- history of gallblader stones
- history of gastric mucosa inflammation
- arterial blood pressure >145/100 mmHg
- use of medication for kinetosis other than the study drugs
Sites / Locations
- Centro Universitário Serra dos Órgãos - UNIFESO
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test combination
Comparative medication
Arm Description
Gamma-aminobutyric acid tartrate 100mg, glutamic acid 100mg, dibasic calcium phosphate 50mg, thiamine nitrate 25mg, pyridoxine hydrochloride 10mg and cyanocobalamin 5mcg
Ginger extract 160mg (8mg gingerols)
Outcomes
Primary Outcome Measures
motion sickness assessment questionnaire
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05221892
First Posted
November 10, 2021
Last Updated
May 15, 2023
Sponsor
Fundação Educacional Serra dos Órgãos
1. Study Identification
Unique Protocol Identification Number
NCT05221892
Brief Title
Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundação Educacional Serra dos Órgãos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
Keywords
vertigo, gamma aminobutyric acid, calcium, glutamic acid, thiamine, pyridoxine, cyanocobalamin, ginger
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test combination
Arm Type
Experimental
Arm Description
Gamma-aminobutyric acid tartrate 100mg, glutamic acid 100mg, dibasic calcium phosphate 50mg, thiamine nitrate 25mg, pyridoxine hydrochloride 10mg and cyanocobalamin 5mcg
Arm Title
Comparative medication
Arm Type
Active Comparator
Arm Description
Ginger extract 160mg (8mg gingerols)
Intervention Type
Drug
Intervention Name(s)
Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin
Other Intervention Name(s)
Gamma-aminobutyric acid tartarate, and combinations
Intervention Description
Tablets to be taken 30 minutes before each of 4 trips.
Intervention Type
Drug
Intervention Name(s)
Ginger
Other Intervention Name(s)
Zingiber officinale
Intervention Description
Tablets to be taken 30 minutes before each of 4 trips.
Primary Outcome Measure Information:
Title
motion sickness assessment questionnaire
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinical kinetosis
female study subjects must agree in using contraceptives during study period
dated informed consent read, understood and undersigned
Exclusion Criteria:
hypersensitivity to the drugs of the study
history of gallblader stones
history of gastric mucosa inflammation
arterial blood pressure >145/100 mmHg
use of medication for kinetosis other than the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
carlos p nunes, MD
Organizational Affiliation
Fundação Educacional Serra dos Órgãos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário Serra dos Órgãos - UNIFESO
City
Teresópolis
State/Province
RJ
ZIP/Postal Code
25964004
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25848702
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.
Results Reference
background
PubMed Identifier
11211039
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.
Results Reference
background
PubMed Identifier
9815340
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.
Results Reference
background
PubMed Identifier
10518003
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.
Results Reference
background
PubMed Identifier
17950516
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.
Results Reference
background
PubMed Identifier
18564850
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.
Results Reference
background
PubMed Identifier
31490017
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.
Results Reference
background
PubMed Identifier
29253614
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.
Results Reference
background
Citation
Zempleni J, Suttie JW, Gregory JF III, Stover PJ. Handbook of Vitamins. Boca Raton, Florida, USA: CRC Press; 2013.
Results Reference
background
PubMed Identifier
3537898
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.
Results Reference
result
PubMed Identifier
10793599
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.
Results Reference
result
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Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo
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