A Phase 4 interventional study of Z. officinale extract in Motion Sickness, sponsored by Fundação Educacional Serra dos Órgãos. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Fundação Educacional Serra dos Órgãos · Phase 4, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 184 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Fundação Educacional Serra dos Órgãos is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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 3
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 3 in relation to pretreatment scores.
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
Percentage of patients presenting change of 20 or more points on total MSAQ scores at Assessment 4 in relation to pretreatment scores.
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
Percentage of patients presenting change on MSAQ subscores at Assessment 2 in relation to pretreatment scores.
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
Percentage of patients presenting change on MSAQ subscores at Assessment 3 in relation to pretreatment scores.
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
Percentage of patients presenting change on MSAQ subscores at Assessment 4 in relation to pretreatment scores.
Time frame: 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
Time frame: From first dose to end of study (no more than 7 days from Pretreatment visit date)
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.
Time frame: Scores taken at pretreatment and at the end of the treatment period (no more than 7 days).
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Apr 2019, 3 months.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Fundação Educacional Serra dos Órgãos