Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- MSAQ total score change at Assessment 2
研究概览
简要总结
This is an open-label, case control study of 180 patients presenting motion sickness, who will perform a motion sickness assessment questionnaire before and after treatment with dry ginger (Z. officinale) extract.
详细描述
This open-label, self-paired, case-control study will evaluate 180 patients presenting motion sickness. The primary study objective is to evaluate the use of dry Z. officinale extract 160mg (containing 8mg gingerol) in the treatment of patients presenting motion sickness. The secondary objectives are to evaluate the effect of the treatment on the scores and subscores of the Motion Sickness Assessment Questionnaire (MSAQ) before and after treatment, as well as to assess treatment tolerability in this population. The total study duration will be seven days. A total of four specific motion sickness assessments will be performed, one pre-treatment and three during the treatment period, which consists of an oral dose of 160mg ginger extract 30 minutes prior to the trip under evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Patients of both sexes between the ages of 18 and 65
- •Clinical presentation of motion sickness
- •Female participant of reproductive age agrees to use birth control during study period
- •Patient has read, understood, signed and dated informed consent document
排除标准
- •Hypersensitivity to any component of the study drug
- •History of biliary calculus
- •History of gastric irritation
- •Hypertension > 145 / 100mmHg
- •Concomitant use of other medicinal products for the treatment of motion sickness
研究组 & 干预措施
Treatment
Oral treatment with single-dose 160mg Z. officinale extract in tablet form.
干预措施: Z. officinale extract (Drug)
结局指标
主要结局
MSAQ total score change at Assessment 2
时间窗: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 2 in relation to pretreatment scores.
次要结局
- MSAQ total score change at Assessment 3(MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.)
- MSAQ total score change at Assessment 4(MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.)
- MSAQ subscore change at Assessment 2(MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.)
- MSAQ subscore change at Assessment 3(MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.)
- MSAQ subscore change at Assessment 4(MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.)
- Adverse event occurrence(From first dose to end of study (no more than 7 days from Pretreatment visit date))
研究者
Carlos Pereira Nunes
Principal Investigator
Fundação Educacional Serra dos Órgãos