Evaluation of Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine and Cyanocobalamin as Therapy for Vertigo
Condition: Vertigo
MeSH terms: Vertigo; Dizziness
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin; Ginger
Intervention type(s): Drug; Drug
Intervention description(s): Tablets to be taken 30 minutes before each of 4 trips.; Tablets to be taken 30 minutes before each of 4 trips.
Other intervention name(s): Gamma-aminobutyric acid tartarate, and combinations; Zingiber officinale
Intervention MeSH terms: Thiamine; Pyridoxine; Vitamin B 12; Hydroxocobalamin; gamma-Aminobutyric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vertigo; gamma aminobutyric acid; calcium; glutamic acid; thiamine; pyridoxine; cyanocobalamin; ginger