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临床试验/NCT05221892
NCT05221892已完成4 期

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

Fundação Educacional Serra dos Órgãos1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2021年11月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
334
试验地点
1
主要终点
motion sickness assessment questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Test combination

Experimental

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

干预措施: Gamma-aminobutyric acid tartarate, glutamic acid, dibasic calcium phosphate, thiamine nitrate, pyridoxine chloride and cyanocobalamin (Drug)

Comparative medication

Active Comparator

Ginger extract 160mg (8mg gingerols)

干预措施: Ginger (Drug)

结局指标

主要结局

motion sickness assessment questionnaire

时间窗: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Pereira Nunes

professor

Fundação Educacional Serra dos Órgãos

研究点 (1)

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