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NCT Number: NCT03755596

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

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.

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Key information

Conditions

Motion Sickness Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Z. officinale extract

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fundação Educacional Serra dos Órgãos

Other

Collaborators

  • Melora do Brasil Produtos Dermatológicos S/A

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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