Effect of Honey- Ginger mouthwash on Oral Mucositis
Design
This intervention is a double-blind clinical practice and will use clinical examination and study of patients' files (manual and electronic) to collect data. With the permission of Kashan University of Medical Sciences and the approval of the Ethics Committee, patients eligible to study n patients will be selected and assigned to two control and intervention groups (ginger mouthwash) with the help of block randomization model with 4 and 6 blocks.
Settings and conduct
After admission to the mouthwash intervention group, 600 mg (containing 300 mg of honey and 60 mg of ginger)
It is given to the oral control group containing 600 mg of normal saline.
Patients are asked to use 15 CC mouthwash every 2 minutes for 4 minutes at a dose (every 6 hours) and for 2 weeks (in the mouth and then in the mouth) and for half an hour after eating and drinking and avoid washing your mouth.
Participants/Inclusion and exclusion criteria
Having chemotherapy-induced mucositis; the patient must be at least 18 years old; patients have a definite diagnosis of cancer; no history of allergies; patients without systemic problems weaken the immune system.
Output criteria: patients who received radiation therapy during the intervention; patients who received local anesthetic during the study; use another mouthwash during the study; patients who refused to quit smoking and did not eat spicy, acidic or spicy foods; patients with severe systemic problems.
Intervention groups
The control and intervention group are both chemotherapy patients who receive the ginger mouthwash intervention group and the 0.9% normal saline control group.
Main outcome variables
The severity of the pain; the severity of the mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N32
Registration date:2020-08-23, 1399/06/02
Registration timing:prospective
Last update:2020-08-23, 1399/06/02
Update count:0
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-15, 1399/06/25
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Honey- Ginger mouthwash on Oral Mucositis in Patients under Chemotherapy in Kashan Shahid Beheshti Hospital in 2020
Public title
Effect of Honey- Ginger mouthwash on Oral Mucositis in Patients under Chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having chemotherapy-induced mucositis
Agree to participate in the study
The patient must be at least 18 years old
Patients have a definitive diagnosis of cancer (histological confirmation)
Oral hygiene
No history of allergies (asthma, allergic rhinitis)
Patients without systemic problems weaken the immune system
Absence of allergic diseases
Exclusion criteria:
Patients who received radiation therapy during the intervention
Announcing the patient's non-cooperation at any stage of the project
Patients who received local anesthetic during the study
Use another mouthwash during the study
Patients who refused to quit smoking and did not eat spicy, acidic or spicy foods.
Patients with severe systemic problems (uncontrolled diabetes, advanced liver and kidney disease)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This intervention is a type of double-blind clinical practice and will use clinical examination and study of patients' files (manual and electronic) to collect data. With the permission of Kashan University of Medical Sciences and the approval of the ethics committee, 80 patients will be selected from the eligible patients and will be assigned to two control and intervention groups (ginger mouthwash) with the help of block randomization model with 4 and 6 blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
1) In pharmaceutical bottles, a certain amount of ginger is used to homogenize its taste with mouthwash.
2) Bottles used for placebo and mouthwash are dark in color to hide the contents of the bottles.
3) Bottles containing mouthwash and placebo are marked in the absence of the researcher
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard, Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-05-19, 1399/02/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.011
Health conditions studied
1
Description of health condition studied
Oral Mucositis in Patients under Chemotherapy
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy
Primary outcomes
1
Description
The severity of the pain
Timepoint
Before Intervention and day 7 and day14
Method of measurement
The VAS scale is given from zero to 10.
2
Description
The severity of the mucositis
Timepoint
Before Intervention and day 7 and day14
Method of measurement
Based on WHO mucositis evaluation criteria
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: the oral intervention group receives 4% ginger extract and 7% honey obtained from the Biochemistry and Nutrition Research Center of Kashan University of Medical Sciences and rinses twice a day for 2 weeks, 3 times a day for 2 tablespoons for 1 minute each.
Category
Treatment - Drugs
2
Description
Control group: the oral intervention group receives 9% normal saline (Iran Injection and Pharmaceutical Products Company) and rinses twice a day for 2 weeks, 3 times a day for 2 tablespoons for 1 minute each.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital of Kashan
Full name of responsible person
Fateme Sadat Razavi
Street address
Shahid Beheshti Hospital, Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
871581151
Phone
+98 31 5557 8010
Fax
+98 31 5557 8011
Email
fatemee.razavii1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Kashan University of Medical Sciences, Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5557 8010
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Elahe Ghasem Zade Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Diagnosis of oral diseases
Street address
Kashan, Qutb Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
55578010
Fax
Email
fatemee.razavii1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr elahe qasemzade hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Kashan, Qutb Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
55578010
Email
el.qasemzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fateme Razavi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Kashan, Qutb Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
55578010
Email
fatemee.razavii1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as pain severity, mucositis severity, age, sex, and type of disease, can be disseminated
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analyzes related to promoting the scientific awareness of researchers and helping modern science are allowed
What processes are involved for a request to access data/document
An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request