A Phase 4 interventional study of Z. officinale extract in Motion Sickness, sponsored by Fundação Educacional Serra dos Órgãos. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Fundação Educacional Serra dos Órgãos · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Oral treatment with single-dose 160mg Z. officinale extract in tablet form.
Drug: Z. officinale extract
Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.
MSAQ total score change at Assessment 2
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 2 in relation to pretreatment scores.
Time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ total score change at Assessment 3
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.
Time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ total score change at Assessment 4
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.
Time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 2
Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.
Time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 3
Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.
Time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 4
Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.
Time frame: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
Adverse event occurrence
Number of subjects reporting adverse effects during treatment period
Time frame: From first dose to end of study (no more than 7 days from Pretreatment visit date)
Physician Assessment score change
Mean Physician Assessment (10-point scale assessing overall patient condition ranging from 1 \[worst\] to 10 \[best\]) score improvement at end-of-study visit compared to pretreatment scores.
Time frame: Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).
Plan to share: No
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Fundação Educacional Serra dos Órgãos