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

• Sponsor: Fundação Educacional Serra dos Órgãos (Other)
• Overall Status: Completed
• CT.gov ID: NCT03755596
• Collaborator: Melora do Brasil Produtos Dermatológicos S/A (Other)
• Enrollment: 184
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 31.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Motion Sickness	Drug: Z. officinale extract	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open-label, single-group, self-paired studyOpen-label, single-group, self-paired study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
• Actual Study Start Date: Jan 2, 2019
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. MSAQ total score change at Assessment 2 [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.

Secondary Outcome Measures

1. 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.]

   Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.

2. 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.]

   Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.

3. MSAQ subscore change at Assessment 2 [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.

4. MSAQ subscore change at Assessment 3 [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.

5. MSAQ subscore change at Assessment 4 [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.

6. Adverse event occurrence [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

Other Outcome Measures

1. Physician Assessment score change [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Universitário Serra dos Órgãos - UNIFESO	Teresópolis	RJ	Brazil	25964004

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carlos Pereira Nunes, Principal Investigator, Fundação Educacional Serra dos Órgãos
• ClinicalTrials.gov Identifier: NCT03755596
• Other Study ID Numbers: ZOTC 01-05-18
• First Posted: Nov 28, 2018
• Last Update Posted: Sep 25, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carlos Pereira Nunes, Principal Investigator, Fundação Educacional Serra dos Órgãos: Zingiber officinale; Motion sickness; Motion sickness assessment questionnaire
• Additional relevant MeSH terms: Motion Sickness

Study Results

No Results Posted as of Sep 25, 2019