Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo

Vertigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221892
• Other study ID #: 50635421.30000.5247
• Status: Completed
• Phase: Phase 4
• Start date: November 22, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Fundação Educacional Serra dos Órgãos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Drug:
• Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin
Tablets to be taken 30 minutes before each of 4 trips.
• Ginger
Tablets to be taken 30 minutes before each of 4 trips.

Locations

Country	Name	City	State
Brazil	Centro Universitário Serra dos Órgãos - UNIFESO	Teresópolis	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Educacional Serra dos Órgãos

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Zempleni J, Suttie JW, Gregory JF III, Stover PJ. Handbook of Vitamins. Boca Raton, Florida, USA: CRC Press; 2013.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year