This study will be conducted in the surgery department of Rahmon Hospital, Yazd. The patients will be divided into two groups receiving Xintoma capsule and placebo by random permutation block method. Each patient will be identified with a number and the list of numbers of people who should be placed in each group will be given to the nurses and the participants, researchers, doctors And the data collectors will be unaware of this list.
Participants/Inclusion and exclusion criteria
Input ctiteria include:Age 16 years and older - Admitted to Rahmon hospital in Yazd due to cholecystectomy - Not receiving antiemetic drugs - Not taking Zintoma drug in the past one month - No history of allergic reaction to oral ginger - Tolerating the oral drugs - Being admitted to the internal surgery department General for 2 days - informed consent of the patient or his legal guardian
Exclusion criteria:Pregnancy or breastfeeding Receiving chemotherapy drugs
Intervention groups
Intervention group: Receiving zintoma tablet 250 mg Goldaru factory ,Take two capsules orally one hour before cholecystectomy surgery to reduce nausea and vomiting after surgery
Control group: Receiving placebo witch was prepared in the pharmaceutical laboratory of Yazd Faculty of Pharmacy in the same size and color as Zintoma tablets , take two orally one hour before the cholecystectomy surgery to prevent nausea and vomiting after the operation.
Main outcome variables
Severity of nausea and vomiting and risk of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190911044744N2
Registration date:2023-11-25, 1402/09/04
Registration timing:registered_while_recruiting
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Ehsan Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 5885
Email address
ehsan.mirzaei.1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness and safety of ginger in preventing nausea and vomiting after cholecystectomy: a double-blind clinical trial
Public title
Investigating the effectiveness and safety of ginger in preventing nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 16 years and older - Admitted to Rahmon hospital in Yazd due to cholecystectomy - Not receiving antiemetic drugs - Not taking Zintoma drug in the past one month - No history of allergic reaction to oral ginger - Tolerating the use of oral drugs - Being admitted to the internal surgery department General for 2 days - informed consent of the patient or his legal guardian
Exclusion criteria:
Pregnancy or breastfeeding
Receiving chemotherapy drugs
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are divided into 25-person groups.using the statistical software,25 out of 50 patients are randomly assigned to treatment group and 25 to placebo group.
Unit of randomization: lndividual.
Tools used in randomization:computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the principle investigator, the physicians and the data collectors are blinded. The patients who are going to receive the drug or placebo , are determined by numbers and these numbers are given to the head nurse and nurses of surgery department.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Faculty of Pharmacy,Yazd, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.133
Health conditions studied
1
Description of health condition studied
Prevention of nausea and vomiting after surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Prevention of severe nausea and vomiting
Timepoint
Two, four, six and twelve hours after surgery
Method of measurement
questionnaire
Secondary outcomes
1
Description
Bleeding risk
Timepoint
2-4-6-12 hours after the operation
Method of measurement
blood test
Intervention groups
1
Description
Intervention group: Receiving zintoma tablet 250 mg Goldaru factory ,Take two capsules orally one hour before cholecystectomy surgery to reduce nausea and vomiting after surgery
Category
Treatment - Drugs
2
Description
Control group: Receiving placebo witch was prepared in the pharmaceutical laboratory of Yazd Faculty of Pharmacy in the same size and color as Zintoma tablets , take two orally one hour before the cholecystectomy surgery to prevent nausea and vomiting after the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
rahnemoun hospital
Full name of responsible person
Ehsan mirzaei
Street address
Farrokhi St., Shahid Dr. Rahmonun Hospital, Yazd
City
Yazd
Province
Yazd
Postal code
۰
Phone
+98 35 3626 0001
Email
ehsan.mirzaei.1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Parisa seifnezhad
Street address
Faculty of pharmacy, Yazd, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Parisaseif95@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
د
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of pharmacy , Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
ehsan.mirzaei.1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of pharmacy, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
ehsan.mirzaei.1369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Parisa seifnezhad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yazd Faculty of pharmacy, Shohada gomnam St., Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
ehsan.mirzaei.1369@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available