This study aimed to evaluate the effects of capsules of Ginger on nausea and vomiting after laparoscopy cholecystectomy surgery. This clinical trail is randomized, double - blind and single center which controlled by placebo.
inclusion criteria include: female, elective laparoscopy Cholecystectomy, informed consent and lack of allergy to Ginger. Exclusion criteria include: Any allergy to Ginger and unwillingness to cooperate in the study.
In this study , 150 patients( female) admitted to the surgery ward of Imam Reza hospital in Mashhad are divided into two groups A and B.
One hour before surgery, in group A two placebo capsules and in group B two Zyntoma capsules ( manufactured by Goldaroo contain 500 mg of Ginger) with 50 ml of water is given to the patients.
General information
Acronym
complementary medicine
IRCT registration information
IRCT registration number:IRCT2016122222218N2
Registration date:2017-01-17, 1395/10/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-17, 1395/10/28
Registrant information
Name
Vahid Moeini Ghamchini
Name of organization / entity
Neyshabour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4062
Email address
v.moinighamchini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-07, 1395/01/19
Expected recruitment end date
2016-11-09, 1395/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of capsules of ginger on nausea and vomiting after laparoscopic cholecystectomy
Public title
Effects of capsules of ginger on nausea and vomiting after laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Females
Obtaining informed consent
People undergoing elective laparoscopic cholecystectomy
Lack of Sensitivity to medicinal plants Ginger
Exclusion criteria:
The patient's unwillingness to continue to cooperate
The occurrence of any allergies and adverse to the ginger
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences
City
mashhad
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR,MUMS.sm.REC.1394.358
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Nausea
Timepoint
In the four levels after surgery (6.4.2 and 12 hours after surgery)
Method of measurement
Nausea based on the severity of nausea (NRS) and vomiting on the based of the number of vomiting after vigilance to 12 hours after surgery
2
Description
Vomiting
Timepoint
In the four levels after surgery (6.4.2 and 12 hours after surgery)
Method of measurement
Nausea based on the severity of nausea (NRS) and vomiting on the based of the number of vomiting after vigilance to 12 hours after surgery
Secondary outcomes
empty
Intervention groups
1
Description
Control group: One hour before surgery, two capsules of placebo with 50 ml of water is given to the patients.
Category
Placebo
2
Description
Intervention group: One hour before surgery, two capsules of 250 mg of ginger (as covered and unknown to the experimenter) with 50 ml of water is given to the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of mashhad
Full name of responsible person
mohammad hasan namaei
Street address
Mashhad University of Medical Sciences
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohammad hasan namaei
Street address
Mashhad University of Medical Sciences
City
mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
mohammad hasan namaei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences
City
mashhad
Postal code
Phone
+98 51 3752 2514
Fax
Email
Namaeemh1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohammad hasan namaei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences
City
mashhad
Postal code
Phone
+98 51 3752 2514
Fax
Email
Namaeemh1@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
vahid moeini ghamchini
Position
master of sciences of nursing
Other areas of specialty/work
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Postal code
Phone
00
Fax
Email
v.moini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)