Evaluation of the effectiveness of Zataria multiflora extract mouthwash on prevention of chemotherapy induced oral mucositis In patients undergoing chemotherapy
Determining the effect of Zataria multiflora extract mouthwash on prevention of chemotherapy induced oral mucositis
Design
A double-blinded randomized clinical trial study with parallel groups (intervention group and control group), phases 3 on 78 patients.Randomization will be done according to block randomization method using R software.
Settings and conduct
Based on the inclusion criteria, 78 samples from Iran Mehr Birjand Hospital patients will be selected and randomly divided into two groups of intervention and control. From the first day of the study, the intervention group will receive mouthwash containing Zataria Multiflora and the control group will receive the placebo. All the patients will undergo an oral examination on days 0, 7, 14 and 21 to check the severity of mucositis (according to World Health Organization scale), pain and the incidence time of mucositis.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Chemotherapy is indicated,
Age should be between 20 and 70 years,
Be alert and able to use mouthwash,
The chemotherapy regimen should contain 5-fluorouracil.
Exclusion criteria:
The presence of traumatizing teeth or traumatizing dentures,
Receiving radiotherapy in addition to chemotherapy,
Pregnancy or breastfeeding.
Intervention groups
The intervention group receives Protect mouthwash containing Zataria Multiflora (Zolang Respina pharmaceutical company) and the control group receives placebo.
Main outcome variables
Mucositis grade, Mucositis incidence time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231126060189N1
Registration date:2024-01-23, 1402/11/03
Registration timing:prospective
Last update:2024-01-23, 1402/11/03
Update count:0
Registration date
2024-01-23, 1402/11/03
Registrant information
Name
Nafiseh Taheri bojd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1718
Email address
nafiseh.taheri.bojd@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Zataria multiflora extract mouthwash on prevention of chemotherapy induced oral mucositis In patients undergoing chemotherapy
Public title
Evaluation of the effect of Zataria multiflora extract mouthwash on prevention of chemotherapy induced oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Chemotherapy is indicated
Age should be between 20 and 70 years
Be alert and able to use mouthwash
The chemotherapy regimen should contain 5-fluorouracil
Exclusion criteria:
The presence of traumatizing teeth or traumatizing dentures
Receiving radiotherapy in addition to chemotherapy
Pregnancy or breastfeeding
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization.
After sampling, using "R" statistical software, individuals without clustering are placed in the placebo and intervention groups through block randomization with block size of 8, so that the size of the two groups is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
A person outside the study codes the mouthwash and placebo, and a code is assigned to each patient. Until the end of the study, the researcher,the evaluator and the participants will not know in which category they have been placed.
The placebo contains all the ingredients of intervention mouthwash except Zataria multiflora. The placebo will be the same color as the intervention mouthwash and will be odorless. The packaging of placebo and intervention mouthwash will be the same.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave , birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.BUMS.REC.1402.328
Health conditions studied
1
Description of health condition studied
chemotherapy induced oral mucositis
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy
Primary outcomes
1
Description
Mucositis grade
Timepoint
Days 0, 7, 14 and 21 after starting cancer treatment
Method of measurement
Clinical examination by a dentist based on World Health Organization oral mucositis grading scale.
Secondary outcomes
1
Description
Pain index
Timepoint
Days 0, 7, 14 and 21 after starting cancer treatment
Method of measurement
Visual Analogue Scale and McGill Pain Questionnaire
2
Description
Mucositis incidence time
Timepoint
Days 0, 7, 14 and 21 after starting cancer treatment
Method of measurement
Weekly clinical examination by a dentist
Intervention groups
1
Description
Intervention group: For 21 days, three times a day and half an hour before chemotherapy, they gargle 5 ml of Protect containing Zataria Multiflora(Zulang Respina Pharmaceutical Company) mouthwash for 1 minute.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: For 21 days, three times a day and half an hour before chemotherapy, they gargle 5 ml of placebo mouthwash for 1 minute.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranmehr Hospital
Full name of responsible person
Mohamad Amir Mohamadifard
Street address
Ghaffari, Iran Mehr Hospital
City
birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6800
Email
iranmehr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
Ghaffari AVE., University of Medical Sciences
City
birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohamad Amir Mohamadifard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Ghaffari AVE, Iran Mehr Hospital
City
birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6800
Email
mohamadamir_mohamadifard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Leili Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran AVE. , School of Dentistry
City
birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
alizadeh۱۳۶۴۲۰۰۱@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nafiseh Taheri bojd
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Ghaffari Ave , birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1718
Fax
Email
nafiseh.taheri.bojd@bums.ac.ir
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