NCT03755596

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Fundação Educacional Serra dos Órgãos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-01-02
• Primary completion: 2019-04-30
• Completion: 2019-06-30
• First posted: 2018-11-28
• Last updated: 2019-09-25

Locations

1 site across 1 country: Brazil