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

Primary Purpose

Motion Sickness

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Z. officinale extract

About this trial

This is an interventional treatment trial for Motion Sickness focused on measuring Zingiber officinale, Motion sickness, Motion sickness assessment questionnaire

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centro Universitário Serra dos Órgãos - UNIFESO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Oral treatment with single-dose 160mg Z. officinale extract in tablet form.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 subscore change at Assessment 2

Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.

MSAQ subscore change at Assessment 3

Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.

MSAQ subscore change at Assessment 4

Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.

Adverse event occurrence

Number of subjects reporting adverse effects during treatment period

Full Information

NCT ID

NCT03755596

First Posted

November 23, 2018

Last Updated

September 24, 2019

Sponsor

Fundação Educacional Serra dos Órgãos

Collaborators

Melora do Brasil Produtos Dermatológicos S/A

1. Study Identification

Unique Protocol Identification Number

NCT03755596

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 2, 2019 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundação Educacional Serra dos Órgãos

Collaborators

Melora do Brasil Produtos Dermatológicos S/A

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Motion Sickness

Keywords

Zingiber officinale, Motion sickness, Motion sickness assessment questionnaire

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

184 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Oral treatment with single-dose 160mg Z. officinale extract in tablet form.

Intervention Type

Drug

Intervention Name(s)

Z. officinale extract

Intervention Description

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

Primary Outcome Measure Information:

Title

MSAQ total score change at Assessment 2

Description

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.

Secondary Outcome Measure Information:

Title

MSAQ total score change at Assessment 3

Description

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.

Title

MSAQ total score change at Assessment 4

Description

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.

Title

MSAQ subscore change at Assessment 2

Description

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.

Title

MSAQ subscore change at Assessment 3

Description

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.

Title

MSAQ subscore change at Assessment 4

Description

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.

Title

Adverse event occurrence

Description

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)

Other Pre-specified Outcome Measures:

Title

Physician Assessment score change

Description

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Centro Universitário Serra dos Órgãos - UNIFESO

City

Teresópolis

State/Province

ZIP/Postal Code

25964004

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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