Clinical trial NCT05221892: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vertigo
Keywords: vertigo
gamma aminobutyric acid
calcium
glutamic acid
thiamine
pyridoxine
cyanocobalamin
ginger
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: motion sickness assessment questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Teresópolis
country: Brazil
facility: Centro Universitário Serra dos Órgãos - UNIFESO
state: RJ
Study officials:
affiliation: Fundação Educacional Serra dos Órgãos
name: carlos p nunes, MD
role: PRINCIPAL_INVESTIGATOR
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