Determination of the effect of mouthwash extract of pomegranate seed on the improvement of stomatitis in patients undergoing chemotherapy
Design
The group of routine mouthwash and group of routine mouthwash added Pomegranate extract.
Settings and conduct
Chemotherapy ward
Participants/Inclusion and exclusion criteria
This double-blind clinical trial study was conducted in Kashan, Iran in 2018, undergoing chemotherapy and suffering from oral stomatitis and treated with an anti-inflammatory drug.
Intervention groups
To all patients after admission are given gloomy bottles of mouth wash solution . experimenttal group containing pomegranate extract + lidocaine 2%, Al-mg-s syrup, diphenhydramine syrup, nystatin drop, diphenhydramine syrup (glass 1), and solvent control group A routine ampoule of lidocaine 2%, Al-mg-s syrup, diphenhydramine syrup, nystatin drop, daphenhydramine syrup.
Main outcome variables
Severity of degree of stomatitis
General information
Reason for update
Acronym
Pomeggranate seed extract and stomatitis
IRCT registration information
IRCT registration number:IRCT20100829004655N10
Registration date:2018-09-17, 1397/06/26
Registration timing:prospective
Last update:2018-09-17, 1397/06/26
Update count:0
Registration date
2018-09-17, 1397/06/26
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mouth wash pomegranate seed extracts on improving oral mucositis in patients treated with chemotherapy
Public title
Effect of pomegranate seed extract on the improvement of stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing chemotherapy
Having consciousness
Age above 18 years old
Satisfaction with participation in the study
Non-allergenic to herbal products
Exclusion criteria:
Getting radiotherapy during research
Fever
Use of other mouthwashes other than mouthwashes defined in this study
The patient's decision to withdraw from the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Cancer patients who are continually referred to randomly assigned block randomization based on a computer spss program will be divided into two groups: intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients have no information about the kind of consultation that receive
Placebo
Used
Assignment
Parallel
Other design features
In this study, the following people were blind and did not know of the content two glass: 1) the person who gave the glass to the patients and examine the patients' oral mucosa 2) patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
kashan University of Medical Sciences , Km 5 ghotb Radvandi Blvd.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2018-07-30, 1397/05/08
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.032
Health conditions studied
1
Description of health condition studied
Stomatitis
ICD-10 code
k12.1
ICD-10 code description
Stomatitis
Primary outcomes
1
Description
stomatitis
Timepoint
Before intervention, days 1, 7 and 14 after intervention
Method of measurement
Standardized checklist stomatitis WHO
Secondary outcomes
1
Description
Change grade of stomatitis
Timepoint
Before intervention, days 1, 7 and 14 after intervention
Method of measurement
Standardized checklist stomatitis WHO
Intervention groups
1
Description
The intervantion group use solution of routine + Pomegranate seed extract, each 100 cc containing lidocaine 2%, 50 mg (2.5.2 cc), 6 cc nystatin drop, Al-mg-s syrup 27.5 cc, Diphenhydramine 14 cc and 50 cc syrup of extract Pomegranate seed (50 to 50%) 4 times a day, for 14 days after breakfast, lunch, dinner, and before bed, 15 cc each time and keep it for 3 minutes, then These patients should not wash their mouths and give them an hour to eat food. Considering the two-sidedness of the study, oral mucosa on the first, seventh and fourteenth days by a nurse trained in the ancology department who does not lnow the mouthwash solution and then checklist is completed .
Category
Treatment - Drugs
2
Description
Control group: Routine mouthwash (lidocaine 2% 100 mg (5 cc), 12 cc nystatin drop, AL-mg-s 55 cc, diphenhydramine syrup 28 cc) 4 times a day, for 14 days after breakfast, lunch, Dinner, and before bed, 15 cc each time and keep it for 3 minutes. Then they should be discarded. These patients should not wash their mouths and give them up to one hour of food intake, and according to double-blind In the study, the oral mucosa on the first, seventh and fourteenth days is checked by the nurse in the oncology nurse who is unaware of the type of mouthwash and the checklist is completed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti medical education Center of Kashan university of medical Sciences
Full name of responsible person
Taghadosi Mohsen
Street address
Kashan University of Medical Sciences , Arctic Blvd Ravandi-
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@Kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Gholamali
Street address
Arctic Blvd Ravandi , Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@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
Mohsen Taghadosi
Position
Ph.D,Faculty member Assistant professor, director of journal pheyz-Head of Nursing and Midwifery Fac
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi, Kashan Universitr of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@Kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghadosi
Position
ph.D, Faculty member Assistant professor, director of journal pheyz, Head of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi , Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@Kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fahimeh Ganjoori
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arctic Blvd Ravandi , Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
taghadosi_m@Kaums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
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
Only available to scholars working in academia and academia
Under which criteria data/document could be used
If you observe trust and mention the source, the data can be used by researchers
From where data/document is obtainable
Send the following e-mail to the following address: taghadosi_m@Kaums.ac.ir
What processes are involved for a request to access data/document
After receiving the letter via email, your request will be reviewed within 2 weeks, and the data will be sent to the applicant at the discretion.