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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05221892
Enrollment
334
Registered
2022-02-03
Start date
2021-11-22
Completion date
2023-03-31
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertigo

Keywords

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

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.

Interventions

DRUGGamma-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.

DRUGGinger

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

Sponsors

Fundação Educacional Serra dos Órgãos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
motion sickness assessment questionnaire1 yearThe 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026