This study is a randomized, double-blinded, placebo-controlled trial which determines the efficacy of Ginger in reducing post operative nausea and vomiting in infertilized women after gynecologic laparoscopic surgery. A total number of 100 patients, aged between 20 to 50 years who were satisfied in participating in this study and referred to Tehran Taleghani Hospital for gynecologic laparoscopic surgery have selected. If they have the following features, will be excluded from the study: patients with ASA grade 3 and above, diabetic patients , smokers, patients with a history of gastriintestinal tract problems, consumers of calcium channel blocker drugs or anticoagulant drugs such as aspirin, warfarin, and ... , Alcoholics. Clinical outcomes in this study are post operative nausea and vomiting . The patients are divided into two groups by random allocation. Group A received two capsules of placebo. The patients in group B receive two capsules of Ginger (each capsule contained 250 miligram of powdered Ginger).The intensity of nausea is measured with verbal 11-point numeric rating scale (NRS) and the vomiting by the times of each episode of it by asking from patients at 0-2-6-24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110017681N1
Registration date:2011-10-16, 1390/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Hoda Amini Ranjbar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 1846
Email address
aminiho@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesia Research Center of Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Ginger in reducing post operative nausea and vomiting in infertilized women after gynecologic laparoscopic surgery
Public title
The efficacy of Ginger in reducing post operative nausea and vomiting in infertilized women after gynecologic laparoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: patients aged between 20 to 50 years who are satisfied in participating in the study and referred to Tehran Taleghani Hospital for gynecologic laparoscopic surgery. Exclusion: patients with ASA grade 3 and above; diabetic patients; smokers; patients with a history of gastriintestinal tract problems; consumers of calcium channel blocker drugs or anticoagulant drugs such as aspirin, warfarin, and ... ; Alcoholics.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tabriz University of Medical Sciences
Street address
Golgasht, Azadi street
City
Tabriz
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
5/4/9595
Health conditions studied
1
Description of health condition studied
post operative nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
post operative vomiting
Timepoint
0-2-6-24 hours after surgery
Method of measurement
frequency of vomiting
Secondary outcomes
1
Description
post operative nausea
Timepoint
0-2-6-24 hours after surgery
Method of measurement
The intensity of nausea is measured with verbal 11-point numeric rating scale (NRS), with which the patient is asked to rate severity of nausea between 0 and 10, with 0 corresponding to no symptoms and 10 corresponding to worst possible symptoms.
Intervention groups
1
Description
Group A: two capsules of placebo
Category
Placebo
2
Description
Group B: two capsules of Ginger (each capsule contained 250 milligram of powdered Ginger).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesia Research Center of Shahis Beheshti University Of Medical Sciences
Full name of responsible person
Dr. Maryam Vosoughian\Associated Professor of Shahid Beheshti University Of Medical Sciences
Street address
next to the Shahid Beheshti University of Medical Sciences, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesia Research Center of Shahis Beheshti 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
Tabriz University Of Medical Sciences
Full name of responsible person
Hoda Amini Ranjbar
Position
Resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht, Azadi Street
City
Tabriz
Postal code
Phone
+98 41 1335 5921
Fax
Email
Aminiho@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Jafar Rahimi Panahi
Position
M.D
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht, Azadi Street
City
Tabriz
Postal code
Phone
+98 41 1335 5921
Fax
Email
jrpanahi@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Hoda Amini Ranjbar
Position
Resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht, Azadi Street
City
Tabriz
Postal code
Phone
+98 41 1335 5921
Fax
+98 41 1335 5944
Email
Aminiho@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)