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

NCT05221892 | Completed Phase 4 DMC

• 1 other identifier: 50635421.30000.5247
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertigo

Keywords

vertigo; gamma aminobutyric acid; calcium; glutamic acid; thiamine; pyridoxine; cyanocobalamin; ginger

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test combination

EXPERIMENTAL

Gamma-aminobutyric acid tartrate 100mg, glutamic acid 100mg, dibasic calcium phosphate 50mg, thiamine nitrate 25mg, pyridoxine hydrochloride 10mg and cyanocobalamin 5mcg

Drug: Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin

Comparative medication

ACTIVE COMPARATOR

Ginger extract 160mg (8mg gingerols)

Drug: Ginger

Interventions

Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin DRUG

Tablets to be taken 30 minutes before each of 4 trips.

Also known as: Gamma-aminobutyric acid tartarate, and combinations

Test combination

Ginger DRUG

Tablets to be taken 30 minutes before each of 4 trips.

Also known as: Zingiber officinale

Comparative medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical kinetosis
• female study subjects must agree in using contraceptives during study period
• dated informed consent read, understood and undersigned

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead

Study Sites (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

Location

Related Publications (11)

• 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: 25848702 BACKGROUND

• 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: 11211039 BACKGROUND

• 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: 9815340 BACKGROUND

• 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: 10518003 BACKGROUND

• 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: 17950516 BACKGROUND

• 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: 18564850 BACKGROUND

• 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: 31490017 BACKGROUND

• 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.

  PMID: 29253614 BACKGROUND

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

  BACKGROUND

• 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: 3537898 RESULT

• 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.

  PMID: 10793599 RESULT

MeSH Terms

Conditions

Vertigo

Interventions

Glutamic Acid; calcium phosphate, dibasic, anhydrous; Thiamine; Vitamin B 12; ginger extract

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Excitatory Amino Acids; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Corrinoids; Tetrapyrroles; Pyrroles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• carlos p nunes, MD

  Fundação Educacional Serra dos Órgãos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: February 3, 2022
• Study Start: November 22, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)