Postoperative Nausea and VomitingPhase 2NCT03626441
The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting
A Phase 2 study testing Ginger in people with Postoperative Nausea and Vomiting, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteJamaica
- Study dates
- 2 Dec 2017to 14 Jun 2018
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Undergoing elective intra-abdominal, gynaecological surgery
Who cannot join
- Allergy to ginger, ginger by-products or cornstarch
- Gastroesophageal reflux disease (GERD)
- Allergy to any of the Anaesthesia Agents
- Inability to swallow capsules.
- psychiatric illness which prevents patients giving informed consent.
- Psychological which prevents patients giving informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Effectiveness of a Single Dose of Preoperative Ginger on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Elective Gynaecological Surgery
This study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.
Read the detailed description
Postoperative nausea and vomiting (PONV) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. Gynaecological surgery is considered high risk for PONV.
Ginger is a cheap, widely available and safe natural product in Jamaica and has been found to reduce the incidence of Nausea and vomiting in other clinical situations, such as in pregnancy. It is believed to act via the inhibition of serotonergic receptors.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ginger, Placebo
- Keywords
- Postoperative Nausea and Vomiting, Ginger
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDietary supplement
Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger
PlaceboDietary supplement
Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery. Receives: Dietary Supplement: Placebo |
| Ginger | Experimental | Two coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery. Receives: Dietary Supplement: Ginger; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post operative nausea or vomiting
The proportion of patient who have any episodes of nausea or vomiting following surgery
Measured: 12 hours after surgery
Secondary outcomes (7)
Severity of post operative Nausea and vomiting
Measured using the Rhodes index
Measured: 12 hours after surgery
Severity of post operative Nausea and vomiting
Measured using the Rhodes index
Measured: 24 hours after surgery
Severity of post operative Nausea and vomiting
Measured using the Rhodes index
Measured: 48 hours after surgery
Severity of post operative Nausea and vomiting
Measured using the BARF scale
Measured: 12 hours after surgery
Severity of post operative Nausea and vomiting
Measured using the BARF scale
Measured: 24 hours after surgery
Severity of post operative Nausea and vomiting
Measured using the BARF scale
Measured: 48 hours after surgery
Patient satisfaction
Measured using a questionnaire administered to patient by investigators
Measured: 48 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start2 Dec 2017
- Primary completion12 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quadruple, blind randomized, controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick J Toppin, The University of The West Indies
- Investigators
- Hyacinth Harding, DM, Principal investigator, UWI, Faculty of medical scienccesAndrea Myers, MD, Study director, UWI, Faculty of medical sciencces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626441
- Sponsor's protocol ID
- Anaesthesia20182
- Status last verified
- Aug 2018
- First submitted
- 14 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make patient data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of a Single Dose of Preoperative Ginger on the Incidence of Postoperative Nausea and Vomiting in Patients Undergoing Elective Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT03626441
- Acronym / sponsor ID
- Anaesthesia20182
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, Ginger
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 13 Aug 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 study evaluates the effectiveness of ginger on the incidence of postoperative nausea and vomiting in patients undergoing gynaecological surgery. Half the patients were given an oral dose of ginger preoperatively and half received placebo.
Detailed description
Postoperative nausea and vomiting (PONV) commonly complicate surgery and may lead to a prolonged length of stay in hospital, increased complication rates and decreased patient satisfaction. Gynaecological surgery is considered high risk for PONV.
Ginger is a cheap, widely available and safe natural product in Jamaica and has been found to reduce the incidence of Nausea and vomiting in other clinical situations, such as in pregnancy. It is believed to act via the inhibition of serotonergic receptors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Quadruple, blind randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery. |
| Ginger | Experimental | Dietary Supplement: Ginger, Dietary Supplement: PlaceboTwo coloured capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger, given 2 hours before the scheduled start of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or above
- Undergoing elective intra-abdominal, gynaecological surgery
Key exclusion criteria (6 listed)
- Allergy to ginger, ginger by-products or cornstarch
- Gastroesophageal reflux disease (GERD)
- Allergy to any of the Anaesthesia Agents
- Inability to swallow capsules.
- psychiatric illness which prevents patients giving informed consent.
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 |
|---|---|---|
| GingerCapsules containing 0.5g ginger powder, flavoured with non-active essence of ginger | Dietary supplement | Ginger |
| PlaceboTwo coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger. | Dietary supplement | Ginger, Placebo |
Primary outcome
Incidence of post operative nausea or vomiting
Time frame: 12 hours after surgery
The proportion of patient who have any episodes of nausea or vomiting following surgery
7 secondary outcomes
Severity of post operative Nausea and vomiting
Time frame: 12 hours after surgery
Severity of post operative Nausea and vomiting
Time frame: 24 hours after surgery
Severity of post operative Nausea and vomiting
Time frame: 48 hours after surgery
Severity of post operative Nausea and vomiting
Time frame: 12 hours after surgery
Severity of post operative Nausea and vomiting
Time frame: 24 hours after surgery
Severity of post operative Nausea and vomiting
Time frame: 48 hours after surgery
Patient satisfaction
Time frame: 48 hours post surgery
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 13 Aug 2018.
- Individual participant dataSharing planned: No. There is no plan to make patient data available to other researchers
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Hyacinth Harding, DM principal investigator
UWI, Faculty of medical sciencces
Andrea Myers, MD study director
UWI, Faculty of medical sciencces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginger in people with Postoperative Nausea and Vomiting, run by The University of The West Indies at 1 site in Jamaica.
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 2 inclusion and 6 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 13 Aug 2018. 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 Jamaica. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of post operative nausea or vomiting (time frame: 12 hours after surgery). 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 13 Aug 2018.