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

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.

Study Overview

• Status: Completed
• Conditions: Motion Sickness
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Teresópolis, RJ, Brazil, 25964004
      • Centro Universitário Serra dos Órgãos - UNIFESO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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	From first dose to end of study (no more than 7 days from Pretreatment visit date)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).

Collaborators and Investigators

• Sponsor: Fundação Educacional Serra dos Órgãos
• Collaborators: Melora do Brasil Produtos Dermatológicos S/A

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Zingiber officinale; Motion sickness; Motion sickness assessment questionnaire
• Additional Relevant MeSH Terms: Motion Sickness
• Other Study ID Numbers: ZOTC 01-05-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No