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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03755596

Enrollment

184

Registered

2018-11-28

Start date

2019-01-02

Completion date

2019-06-30

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motion Sickness

Keywords

Zingiber officinale, Motion sickness, Motion sickness assessment questionnaire

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.

Interventions

DRUGZ. officinale extract

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-label, single-group, self-paired study

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MSAQ total score change at Assessment 2	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.	Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 2 in relation to pretreatment scores.

Secondary

Measure	Time frame	Description
MSAQ total score change at Assessment 3	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.	Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.
MSAQ total score change at Assessment 4	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.	Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.
MSAQ subscore change at Assessment 2	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.	Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.
MSAQ subscore change at Assessment 4	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.	Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.
Adverse event occurrence	From first dose to end of study (no more than 7 days from Pretreatment visit date)	Number of subjects reporting adverse effects during treatment period
MSAQ subscore change at Assessment 3	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.	Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.

Other

Measure	Time frame	Description
Physician Assessment score change	Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026