Comparison of the herbal mouthwash containing Syzygium aromaticum and Commiphora molmol with protact on the improvement of first and Second grade of Chemotherapy-induced mucositis
Eٍٍfficacy and safety of herbal mouthwash containing Syzygium aromaticum (L.) Merr. & L.M. Perry and Commiphora molmol (Nees) Engl. on Chemotherapy-induced mucositis
Design
Randomized double-blind trial with a control group
Settings and conduct
Emam Khomeini Hospital, Comprehensive cancer center and Touba superficiality clinic
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Age over 18 years
2. Willing to provide written consent form
3. Grade 1 or 2 of chemotherapy-induced mucositis
Intervention groups
One group will receive mouthwash containing Syzygium aromaticum (L.) and Commiphora molmol and another group will receive protact mouth wash 5 ml three times a day. Intervention will continue until improvement of mucositis or until maximum 10 days after initiation of the treatment.
Main outcome variables
Patients' mucositis and pain severity at baseline (day 1) and then days 3, 5, 7 and 10 based on CTCAT (Common Terminology Criteria for Adverse Events) v5-2017 and World Health Organization (WHO) criteria Evaluations will be evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N19
Registration date:2020-02-08, 1398/11/19
Registration timing:registered_while_recruiting
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the herbal mouthwash containing Syzygium aromaticum and Commiphora molmol with protact on the improvement of first and Second grade of Chemotherapy-induced mucositis
Public title
Comparison of the herbal mouthwash containing Syzygium aromaticum and Commiphora molmol with protact on the chemotherapy-induced mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years of age
Willing to provide written informed consent
First and second grade of chemotherapy-induced mucositis
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For allocation concealment, a 5 numbers digital code obtained from Excel software will be assigned for each patient. Participants will be randomly assigned to the study groups according to block randomization with 4 patients in each block. Random allocation software will be used for block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
For wearing groups A and B, instead of labels A or B, each participant will be assigned a random five-digit code that will be taken from the computer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mazandaran University of Medical Sciences
Street address
mazandaran university of medical science, darya road, sari
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-11-09, 1398/08/18
Ethics committee reference number
IR.MAZUMS.REC.1398.1122
Health conditions studied
1
Description of health condition studied
Cancer patients undergoing chemotherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Primary outcome measures included improvement or termination of mucositis
Timepoint
At the beginning of treatment (day 1) and then on days 3, 5, 7 and 10
Method of measurement
Mucositis severity based on Common Terminology Criteria for Adverse Events and World Health Organization Criteria
Secondary outcomes
1
Description
Pain severity
Timepoint
Days 1, 3, 5, 7, 10
Method of measurement
Based on the pain severity according to Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The mouthwash containing Syzygium aromaticum (5%) and Commiphora molmol (5%) 5 ml three times a day
Category
Treatment - Drugs
2
Description
Control group: The protact mouthwash 5 ml three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Cancer Center, Emam Khomeini hospital, Sari
Full name of responsible person
Eebrahim Salehifar
Street address
Amir Mazandarani Boulevard
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 4047
Email
esalehifar@mazums.ac.ir
2
Recruitment center
Name of recruitment center
Touba Clinic
Full name of responsible person
Ebrahim Salehifar
Street address
Khazar sq, Valliasr Blvd
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
+98 11 3324 9400
Email
esalehifar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Vice chancellor for research of Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4854
Fax
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4818893716
Phone
+98 11 3354 3083
Fax
+98 11 3354 3084
Email
esalehifar@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Fax
Email
esalehifar@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam's Complex of Mazandaran University of Medical Sciences, kilometer 18 of Farah Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Fax
Email
esalehifar@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD