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

NCT ID: NCT05221892

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2023-03-31

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.

Conditions

Vertigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Test combination

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Comparative medication

Ginger extract 160mg (8mg gingerols)

Group Type: ACTIVE_COMPARATOR

Ginger

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Ginger

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

Intervention Type: DRUG

Other Intervention Names

Gamma-aminobutyric acid tartarate, and combinations; Zingiber officinale

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação Educacional Serra dos Órgãos

OTHER

Sponsor Role: lead

Responsible Party

Carlos Pereira Nunes

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

carlos p nunes, MD

Role: PRINCIPAL_INVESTIGATOR

Fundação Educacional Serra dos Órgãos

Locations

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

PMID: 25848702 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11211039 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 9815340 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10518003 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 17950516 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31490017 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29253614 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 3537898 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10793599 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

50635421.30000.5247

Identifier Type: -

Identifier Source: org_study_id