Then the researcher attended in the hematology wards of Shafa And Baghai2 Hospitals and informed writing consent was obtained from patients who were willing to participate in the study. Patients were admitted to the hospital one day before chemotherapy
Participants/Inclusion and exclusion criteria
Patients undergoing chemotherapy in the oncology departments of Shafa and Baghaee 2 Hospitals/Inclusion criteria:Age over 18 years, Acute leukemia under periodic chemotherapy in the induction and intensification phases,Complete alertness-Exclusion criteria:Asthma, allergies, and other sensitivity diseases, Simultaneous chemotherapy and radiotherapy, Development of a systemic infection during the study
Intervention groups
After which, correct use of mouthwash was taught, so that the mouth was washed for one minute with 30 drops of 5% formulation of lasura (Cordia myxa) fruit mucilage poured in 20 mL water; then the mouthwash was spat out, followed by not eating for up to 1 hour. After training, the treatment and the control groups were given lasura mouthwash and sterile water (with the same flavor and taste), respectively, in a glass that has a dropper.
Main outcome variables
Cordia Myxa؛ prevention؛ stomatitis؛ chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180511039610N2
Registration date:2018-10-24, 1397/08/02
Registration timing:registered_while_recruiting
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Bayan saberipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 6702
Email address
saberipour.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cordia Myxa on prevention the effect of mouthwashes fruits of stomatitis (mouth sores) in patients receiving chemotherapy
Public title
Cordia Myxa on prevention the effect of mouthwashes fruits of stomatitis (mouth sores) in patients receiving chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Acute leukemia under periodic chemotherapy in the induction and intensification phases
Complete alertness
Exclusion criteria:
Asthma, allergies, and other sensitivity diseases
Simultaneous chemotherapy and radiotherapy
Development of a systemic infection during the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Cordia Myxa mouthwash and mouthwash after the approval of the pharmacist and an expert oncology participant in the research were coded without the knowledge of the researcher. After obtaining a license from the University's Ethics Committee and explaining to patients undergoing chemotherapy, they were placed in one of the two intervention and placebo groups. And received one of two types of mouthwash.
Placebo
Used
Assignment
Single
Other design features
The present randomized, double-blind, controlled clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
plain 16-Alley of Arasham-In between the Great and the Masjid-Nazari Pour-Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6195734733
Approval date
2018-05-11, 1397/02/21
Ethics committee reference number
IR.Ajums.REC.139.110
Health conditions studied
1
Description of health condition studied
Osteomathite
ICD-10 code
D80-D89
ICD-10 code description
III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Primary outcomes
1
Description
The amount of osteomyte is taken from the WHO standard checklist of osteomathite.
Timepoint
(Before the intervention) , 7 and 14
Method of measurement
The WHO stomatitis checklist, validity and reliability of this checklist has been confirmed.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: On the same day, demographic information of both two groups was recorded and their mouths were examined. Soft toothbrushes were provided to the groups, and correct brushing was taught to them and was exercised, after which, correct use of mouthwash was taught, so that the mouth was washed for one minute with 30 dropsof 5% formulation of lasura (Cordia myxa) fruit mucilage poured in 20 mL water; then the mouthwash was spat out, followed by not eating for up to 1 hour. After training, the treatment.
Category
Prevention
2
Description
Control group: groups were given lasura mouthwash and sterile water (with the same flavor and taste), respectively, in a glass that has a dropper.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa and Baghaee 2 Hospitals
Full name of responsible person
Dr. Bijan Keikhaei Devadzi
Street address
Iran, Ahvaz, Golestan Street
City
Ahvaz
Province
Khouzestan
Postal code
61335-39345
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61335-39345
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Bayan saberipour
Position
Student of Community Health Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3336 2414
Email
bayan.saberipoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3336 2414
Email
shahrambaraz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bayan saberipour
Position
Student of Community Health Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3336 2414
Email
bayan.saberipoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
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
Not applicable
Title and more details about the data/document
All data obtained, except for confidential personal information, can be shared
When the data will become available and for how long
2019
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Noting the source of the use of resources is allowed
From where data/document is obtainable
Saberipour.b@ajums.ac.ir
What processes are involved for a request to access data/document