Status:
COMPLETED
Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
Lead Sponsor:
Fundação Educacional Serra dos Órgãos
Collaborating Sponsors:
Melora do Brasil Produtos Dermatológicos S/A
Conditions:
Motion Sickness
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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. officin...
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 (containin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03755596
Start Date
January 2 2019
End Date
June 30 2019
Last Update
September 25 2019
Active Locations (1)
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1
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, Brazil, 25964004