The Effect of Ginger on the Incidence of Postoperative Na... | NCT03626441

Studies
The Effect of Ginger on the Incidence of Postoperative Nausea and Vomiting

NCT03626441

Sponsor

The University of The West Indies

Status

Completed

Last Update Posted

Aug 13, 2018Actual

Enrollment

110Actual

Phase

Phase 2

Conditions

Postoperative Nausea and Vomiting

Interventions

Ginger
Placebo

Countries

Jamaica

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2017Actual

Primary Completion Date

Jun 12, 2018Actual

Completion Date

Jun 14, 2018Actual

First Submitted Date

Jul 14, 2018

First Submission Date that Met QC Criteria

Aug 7, 2018

First Posted Date

Aug 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 13, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick J Toppin, Associate lecturer, The University of The West IndiesPrincipal Investigator

Lead Sponsor

The University of The West IndiesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Dietary Supplement: Ginger Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ginger	Dietary Supplement	Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger	Ginger

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post operative nausea or vomiting	The proportion of patient who have any episodes of nausea or vomiting following surgery	12 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
Severity of post operative Nausea and vomiting	Measured using the Rhodes index	12 hours after surgery
Severity of post operative Nausea and vomiting	Measured using the Rhodes index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or above
Undergoing elective intra-abdominal, gynaecological surgery

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyacinth Harding, DM	UWI, Faculty of medical sciencces	Principal Investigator
Andrea Myers, MD	UWI, Faculty of medical sciencces	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of the West Indies		Kingston	Kng 7	00000	Jamaica

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to make patient data available to other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713927	ginger extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Quadruple

Masking Description

Sequentially numbered, sealed, opaque envelopes prepared and opened the evening before the surgery. Tablets containing either placebo or ginger allocated by a person not involved in any other aspect of the study and administered on the morning of surgery.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor