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

NCT03755596 | Completed Phase 4

• 1 other identifier: ZOTC 01-05-18
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness

Keywords

Zingiber officinale; Motion sickness; Motion sickness assessment questionnaire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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.

• MSAQ subscore change at Assessment 2

  MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.

• MSAQ subscore change at Assessment 3

  MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.

• MSAQ subscore change at Assessment 4

  MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.

Other Outcomes (1)

• Physician Assessment score change

  Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Z. officinale extract

Interventions

Z. officinale extract DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead
• Melora do Brasil Produtos Dermatológicos S/A: collaborator

Study Sites (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label, single-group, self-paired study

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 28, 2018
• Study Start: January 2, 2019
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)