Motion SicknessPhase 4NCT03755596
Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
A Phase 4 study testing Z. officinale extract in people with Motion Sickness, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Z. officinale extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2019to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, 25964004
About this study
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.
Read the 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.
- Conditions
- Motion Sickness
- Being tested
- Z. officinale extract
- Keywords
- Zingiber officinale, Motion sickness, Motion sickness assessment questionnaire
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z. officinale extractDrug
Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Oral treatment with single-dose 160mg Z. officinale extract in tablet form. Receives: Drug: Z. officinale extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.
Measured: 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
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.
Measured: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 2
Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.
Measured: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 3
Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.
Measured: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
MSAQ subscore change at Assessment 4
Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.
Measured: MSAQ completed within 30 minutes of car, bus, boat, ferry, or train ride lasting at least 15 minutes.
Adverse event occurrence
Number of subjects reporting adverse effects during treatment period
Measured: From first dose to end of study (no more than 7 days from Pretreatment visit date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start2 Jan 2019
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-group, self-paired study
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Educacional Serra dos Órgãos
- Sponsor type
- University, hospital or other
- Collaborators
- Melora do Brasil Produtos Dermatológicos S/A
- Responsible party
- Principal investigator, Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755596
- Sponsor's protocol ID
- ZOTC 01-05-18
- Status last verified
- Sep 2019
- First submitted
- 23 Nov 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Use of Ginger Extract in the Management of Motion Sickness
- ClinicalTrials.gov ID
- NCT03755596
- Acronym / sponsor ID
- ZOTC 01-05-18
- Conditions
- Motion Sickness
- Keywords
- Zingiber officinale, Motion sickness, Motion sickness assessment questionnaire
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Fundação Educacional Serra dos ÓrgãosUniversity, hospital or other
- Collaborators
- Melora do Brasil Produtos Dermatológicos S/A
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-group, self-paired study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Z. officinale extractOral treatment with single-dose 160mg Z. officinale extract in tablet form. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z. officinale extractOral dose of 160mg dry ginger root (Z. officinale) extract in tablet form. | Drug | Treatment |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
Adverse event occurrence
Time frame: From first dose to end of study (no more than 7 days from Pretreatment visit date)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Z. officinale extract in people with Motion Sickness, run by Fundação Educacional Serra dos Órgãos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.