Post-operative nausea and vomiting (PONV) is one of the most common complications of patients under surgery and usually occurs after any protocol of general anesthesia.Previous results showed that synthetic drugs have adverse effects therefor use of other methods such as complementary and alternative therapy may be useful as a therapeutic or suppoative as an independent method or standard therapy in improving treatment of patients.
The purpose of this study was to examine the effect of ginger in preventing Post-operative nausea and vomiting (PONV) . This study is a randomized, double – blinded and clinical trial
Among patients admitted to hospital for abdominal surgery, those free from cancer and willing to participate
. All eligible patients are randomly assigne by fourth block method in two groups A (68) and B(68).
participates receive in Group A, 4 capsules of ginger and participates in Group B, 4 capsules or placebo 1 hour before surgery .
The severity of nausea in both groups measure with using a structured questionnaire and Visual analogue scale at 2, 4 and 6 hours after surgery using and the severity of vomiting is measure with a Kortila standard tool.
The data analyze with using descriptive and inferential statistics
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805202329N1
Registration date:2011-08-01, 1390/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-01, 1390/05/10
Registrant information
Name
Akram Sadat Montazeri
Name of organization / entity
Shahroud University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 27 3333 6501
Email address
montazeri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of shahroud of University Medical sciences
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ginger in preventing nausea and vomiting after surgery in patients referred to Imam Hossein Hospital (AS) anymore 89-1388
Public title
Effect of ginger in nausea and vomiting after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ages between 64-18 years, the ability of swallowing capsules used in the study, the platelet count over a hundred thousand, no risk of bowel obstruction or hepatitis, no pregnancies, no drugs or anti-nausea and vomiting, and drugs causing it lack of long-term treatment with corticosteroids, the lack of sensitivity to history is Ginger
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shahroud University Medical of sciences
Street address
Haft Tir Square-Shahroud University of Medical Sciences
City
shahroud
Postal code
Approval date
2009-08-22, 1388/05/31
Ethics committee reference number
01/880
Health conditions studied
1
Description of health condition studied
Post-operative nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Postprocedural disorder of digestive system, unspecified
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
2 ,4 and 6Hours after Operation
Method of measurement
Observation and complete Tool
Secondary outcomes
empty
Intervention groups
1
Description
4 x 250-mg capsules of ginger, which was given 1 h before surgery
Category
Prevention
2
Description
4 x 250-mg capsules of placebo, which was given 1 h before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hossein hospital
Full name of responsible person
Eisa Nasiri
Street address
shahroud University of medical sciences
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of medical sciences
Full name of responsible person
Ahmad Khosravi
Street address
Shahroud university of Medical Sciences
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Azam Hamidzade
Position
MSc of educational Midwifery
Other areas of specialty/work
Street address
Haft Tir Square-Shahroud University of Medical Sciences
City
Shahroud
Postal code
3614773955
Phone
+98 27 3339 5054
Fax
+98 27 3339 4800
Email
azhamidzade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Akram sadat montazeri
Position
MSc of Nursing/ Faculty
Other areas of specialty/work
Street address
Haft Tir Square-Shahroud University of Medical Sciences
City
shahroud
Postal code
3614773955
Phone
+98 27 3339 5054
Fax
+98 27 3339 4800
Email
m.2009@shmu.ac.irmontazeri@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Akram sadat Montazeri
Position
MSc of Nursing /Faculty
Other areas of specialty/work
Street address
Haft Tir Square-Shahroud University of Medical Sciences
City
Shahroud
Postal code
3614773955
Phone
+98 27 3339 5054
Fax
+98 33 94800
Email
m.2009@shmu.ac.irmontazeri@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)