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

NCT ID: NCT03755596

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2019-06-30

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.

Conditions

Motion Sickness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Oral treatment with single-dose 160mg Z. officinale extract in tablet form.

Group Type: EXPERIMENTAL

Z. officinale extract

Intervention Type: DRUG

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

Interventions

Z. officinale extract

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melora do Brasil Produtos Dermatológicos S/A

UNKNOWN

Sponsor Role: collaborator

Fundação Educacional Serra dos Órgãos

OTHER

Sponsor Role: lead

Responsible Party

Carlos Pereira Nunes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

ZOTC 01-05-18

Identifier Type: -

Identifier Source: org_study_id