Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness

Conditions
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Motion Sickness

Intervention / Treatment
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* Drug: Z. officinale extract


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, single-group, self-paired study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Oral treatment with single-dose 160mg Z. officinale extract in tablet form. | Drug: Z. officinale extract<br>* Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSAQ total score change at Assessment 2 | Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 2 in relation to pretreatment scores. | MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSAQ total score change at Assessment 3 | Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores. | 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 | Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores. | MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes. | 
| MSAQ subscore change at Assessment 2 | Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores. | MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes. | 
| MSAQ subscore change at Assessment 3 | Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores. | MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes. | 
| MSAQ subscore change at Assessment 4 | Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores. | MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes. | 
| Adverse event occurrence | Number of subjects reporting adverse effects during treatment period | From first dose to end of study (no more than 7 days from Pretreatment visit date) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zingiber officinale, Motion sickness, Motion sickness assessment questionnaire