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

Fundação Educacional Serra dos Órgãos184 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Motion Sickness

Interventions

Z. officinale extractDRUG

Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

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.