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

September 24, 2019 updated by: Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MSAQ total score change at Assessment 2
Time Frame: 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.
MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MSAQ total score change at Assessment 3
Time Frame: 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 completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ total score change at Assessment 4
Time Frame: 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 completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 2
Time Frame: 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 completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 3
Time Frame: 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.
MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 4
Time Frame: 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.
MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
Adverse event occurrence
Time Frame: 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
From first dose to end of study (no more than 7 days from Pretreatment visit date)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physician Assessment score change
Time Frame: 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.
Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundação Educacional Serra dos Órgãos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Melora do Brasil Produtos Dermatológicos S/A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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