Overview

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

Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundação Educacional Serra dos Órgãos
Collaborator:
Melora do Brasil Produtos Dermatológicos S/A
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