clinical effectiveness of mouthwash of arctium lappa tincture on the treatment of oral mucositis induced by chemoradiotherapy in patients with head and neck cancer
Determination of the efficacy of mouthwash from infusion of tincture of burdock on mucositis treatment following comorbidotherapy in patients with head and neck cancer
Design
A parallel single blinded randomized clinical trial study
sample size:52 patients
Settings and conduct
this study is a single blind clinical trial on patients with head and neck cancer who are reffered to Rasht Razi hospital.52 patients will attented this study who will be randomely divided into two groups of cases and controls.patients should have grade 3 or 4 mucositis.severiety of mucositis and pain access and record at the begining of the study.patients in case groups are given burdock and Diphenhydramine mouthwash,patients in control groups are given Diphenhydramine mouthwash.the patients take medication for 6 weeks.the severity of the mucositis and pain are accessed once at the begining of the study,after the intervention,and then every week.the information obtained is based on the patient's questionnaire is recorded.allat the begining of the study,form of the agreement will be completed.
Participants/Inclusion and exclusion criteria
All patients with head and neck cancer can be included in the study regardless of age and sex.
Patients with a history of specific systemic disease or a history of allergy to medicinal plants can not be included in the study.
Intervention groups
In the experimental group, mucosal tincture of burdock and
Diphenhydramine mouthwash was used separately.
Main outcome variables
Evaluation of pain and severity of lesion changes and duration of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190114042353N1
Registration date:2019-03-16, 1397/12/25
Registration timing:registered_while_recruiting
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Masood Sepehrimanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
sepehrimaneshmasood@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical effectiveness of mouthwash of arctium lappa tincture on the treatment of oral mucositis induced by chemoradiotherapy in patients with head and neck cancer
Public title
clinical effectiveness of mouthwash of arctium lappa tincture on the treatment of oral mucositis induced by chemoradiotherapy in patients with head and neck cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with head and neck cancer who go to oncology department of"Razi Hospital"
Exclusion criteria:
Patients with any systemic disorder that may interfere with the repair process (such as diabetes)
History of allergy to Arauca family
Pregnant and lactating women
Continuous users of analgesics
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
after accepting participation In the study,a bottle containing a mixture of burdock mouthwash and a diphenhydramine mouthwash was given to the patient that the patient was not aware of its contents.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research center of Guilan University of Medical sciences
Street address
Guilan University of Medical Sciences.,Lakan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.GUMS.REC.1397.411
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
The amount of pain
Timepoint
at the first of study before intervention, then it is measured every week for 6 weeks
Method of measurement
Based on the VAS index
2
Description
Severity of lesion
Timepoint
at the first of study before intervention, then it is measured every week for 6 weeks
Method of measurement
Based on the WHO Scale
3
Description
treatment duration
Timepoint
Total days from the onset of 3-4 degree mucositis symptoms
Method of measurement
Number of days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Mouthwash burdock Tincture + Diphenhydramine mouthwash:The patient should hold 30 drops of mouthwash with some water in his mouth every day, four times a day, and then throw it out.(Before using this mouthwash, they should also use diphenhydramine combination mouthwash).as they should, First, keep 30 drops of mouthwash for 30 seconds and then throw it away.After 30 minutes, use the second mouthwash in the manner described.
Category
Treatment - Drugs
2
Description
Control group: Diphenhydramine combination mouthwash:The patient takes 30 drops of diphenhydramine mouthwash four times a day for 30 seconds in his mouth then throw it away.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital In Rasht
Full name of responsible person
masood sepehrimanesh
Street address
Radiotherapy Department Of Razi Hospital,Sardar Jangal Ave,Rasht
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3353 5116
Email
sepehrimaneshmasood@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Research Affairs, Guilan University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Guilan University of Medical Sciences,2km Fouman Road,Lakan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3332 4168
Fax
+98 13 3332 4168
Email
sepehrimaneshmasood@gmail.com
Web page address
http://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research Affairs, Guilan 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
Rasht University of Medical Sciences
Full name of responsible person
Anahid Lavayii Motlagh
Position
dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences,2km Fouman Road,Lakan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6406
Email
dr.anahid@yahoomail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
masood sepehri manesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Research
Street address
Research Center Lab,Razi Hospital,Sardar Jangal Ave,Rasht
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3353 5116
Email
sepehrimaneshmasood@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Anahid Lavayii Motlagh
Position
dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences,2km Fouman Road,Lakan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6406
Email
dr.anahid@yahoomail.com
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
Care for the secrets of patients
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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