Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- MSAQ total score change at Assessment 2
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment
Oral treatment with single-dose 160mg Z. officinale extract in tablet form.
Intervention: Z. officinale extract (Drug)
Outcomes
Primary Outcomes
MSAQ total score change at Assessment 2
Time Frame: 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.
Secondary Outcomes
- 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))
Investigators
Carlos Pereira Nunes
Principal Investigator
Fundação Educacional Serra dos Órgãos