The effect of ginger on nausea and vomiting during chemotherapy and radiotherapy
Design
The present study is a randomized clinical trial designed to evaluate the effect of ginger on nausea and vomiting during chemotherapy and radiotherapy, and patients (80 patients) will be divided into two groups of control and intervention.
Settings and conduct
The present study is an intervention and will be carried out in Shahid Ghazi Tabatabai and Shahid Madani hospitals.
Participants/Inclusion and exclusion criteria
Attendance criteria: age over 18 years old; definitive diagnosis of cancer by an oncologist and pathologist; history of at least one chemotherapy course; experience of nausea and vomiting after chemotherapy sessions.
Exit criteria: use of Warfarin, Heparin and Aspirin; history of blood disorders; sensitivity to ginger; ginger consumption last week.
Intervention groups
Cancer Patients
Main outcome variables
Nausea; vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120605009948N4
Registration date:2018-11-28, 1397/09/07
Registration timing:registered_while_recruiting
Last update:2018-11-28, 1397/09/07
Update count:0
Registration date
2018-11-28, 1397/09/07
Registrant information
Name
Majid Montazer
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8435
Email address
montazerma@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger on nausea and vomiting during chemotherapy and radiotherapy
Public title
The effect of ginger on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Definitive diagnosis of cancer by an oncologist and pathologist
History of at least one chemotherapy course
Experience of nausea and vomiting after chemotherapy sessions
Exclusion criteria:
Use of Warfarin, Heparin and Aspirin
History of blood disorders
Sensitivity to ginger
Ginger consumption last week
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are simply randomized to two groups , through random number table; received a special code and are treated with own group
Blinding (investigator's opinion)
Not 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
Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5981764867
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.TBZMED.REC.1397.598
Health conditions studied
1
Description of health condition studied
Cancer Patients
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea, Vomiting
Timepoint
Three days before chemotherapy or radiotherapy - Every six hours.
Method of measurement
Using VAS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient will take the drug six days before chemotherapy or radiotherapy. Every six hours, eat a pill containing ginger.
Category
Treatment - Drugs
2
Description
Control group: The patient will take the drug six days before chemotherapy or radiotherapy. Every six hours, eat a starchy pill.