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

Motion Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755596
• Other study ID #: ZOTC 01-05-18
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: Fundação Educacional Serra dos Órgãos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Motion Sickness

Intervention

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

Locations

Country	Name	City	State
Brazil	Centro Universitário Serra dos Órgãos - UNIFESO	Teresópolis	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Fundação Educacional Serra dos Órgãos	Melora do Brasil Produtos Dermatológicos S/A

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)