Clinical trial NCT03755596: Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
Official title: Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Motion Sickness
Keywords: Zingiber officinale
Motion sickness
Motion sickness assessment questionnaire
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
Collaborators: name: Melora do Brasil Produtos Dermatológicos S/A
First posted: 2018-11-28
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single-group, self-paired study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MSAQ total score change at Assessment 2
timeFrame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
Secondary outcomes:
measure: MSAQ total score change at Assessment 3
timeFrame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
measure: MSAQ total score change at Assessment 4
timeFrame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
measure: MSAQ subscore change at Assessment 2
timeFrame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
measure: MSAQ subscore change at Assessment 3
timeFrame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
measure: MSAQ subscore change at Assessment 4
timeFrame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
measure: Adverse event occurrence
timeFrame: From first dose to end of study (no more than 7 days from Pretreatment visit date)
Other outcomes:
measure: Physician Assessment score change
timeFrame: Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).
Locations:
city: Teresópolis
country: Brazil
facility: Centro Universitário Serra dos Órgãos - UNIFESO
state: RJ
Study officials:
References: