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

Fundação Educacional Serra dos Órgãos

Status and phase

Completed

Phase 4

Conditions

Motion Sickness

Treatments

Drug: Z. officinale extract

Study type

Interventional

Funder types

Other

Identifiers

NCT03755596

ZOTC 01-05-18

Details and patient eligibility

About

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.

Full 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.

Enrollment

184 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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