Protocol summary
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Study aim
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Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
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Design
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the group of routine mouth wash and group of "mouthwash solution" added to routine mouth wash
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Settings and conduct
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chemotherapy ward
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Participants/Inclusion and exclusion criteria
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The study population consisted of all cancer patients with oral stomatitis and under chemotherapy treatment with an anti-inflammatory and referred to Shahid Beheshti Medical Center, Kashan, Iran
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Intervention groups
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To all patients after admission, are given gloomy bottles of mouth wash solution (that experimental mouth wash solution contain:lidocaine2%,syrp Al-mg-s,syrp Diphenhydramine and aqueous extract of the Marshmallow root 8%.(glass-1)and the routine solution (lidocaine2℅, Diphenhydramine and Al-mg-s surup,and Nystatin drop)(glass-2)
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Main outcome variables
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pain severity (VAS)
stomatitis stage (according to WHO)
General information
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Reason for update
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Acronym
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Marshmallow root and ostomatitis
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IRCT registration information
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IRCT registration number:
IRCT201307274655N4
Registration date:
2016-07-14, 1395/04/24
Registration timing:
prospective
Last update:
2018-03-01, 1396/12/10
Update count:
1
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Registration date
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2016-07-14, 1395/04/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2016-08-22, 1395/06/01
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Expected recruitment end date
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2016-11-20, 1395/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
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Public title
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Effect of mouth wash contaning marshmallow root extract on improvement stomatitis.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
undergoing chemotherapy
age above18 years old
having consciousness
Exclusion criteria:
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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0
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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sequential patient discharge allocated in 2 group in this study: intervention and control group by computer randomize program (spss)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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patients have no information about the kind of consultation that receive
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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In this study, the following people were blind and did not know of the contents two glass:
1) The person who gave the glass to the patient and examine the patient oral mucosa.
2) Patients.
Ethics committees
1
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Ethics committee
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Approval date
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2016-06-01, 1395/03/12
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Ethics committee reference number
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IR.KAUMS.REC.1395.10
Health conditions studied
1
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Description of health condition studied
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Stomstitis
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ICD-10 code
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K12.1
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ICD-10 code description
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Stomatitis and related lesions
Primary outcomes
1
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Description
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ostomatitis
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Timepoint
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Before and seventh and fourteenth days after the intervention
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Method of measurement
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Standardized checklist stomatitis WHO
Secondary outcomes
1
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Description
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Change grade of stomatitis
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Timepoint
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Beforebefore and seventh and fourteenth days after the intervention
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Method of measurement
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Standardized checklist stomatitis WHO
Intervention groups
1
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Description
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The intervention group use solution of routine mouthwash plus hydro alcholic extract of marshmallow root that each 100m.l of that contains :lidocaine 2% 50 mg ,Al-mg-s syrup 25 ml,Diphen hydramine surp12.5cc(31.25mg) and 60 cc hydro alcholic marshmallow extract root 8% (glass 1).Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after. oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.
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Category
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Treatment - Drugs
2
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Description
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Control group use routine mouthwash solution that100 ml of that containing :lidocaine 2%100mg, Al-mg-s syrup55 ml , Diphenhydramine syrup 28 cc(70mg),nystatin dpop1,200,000 unit(12cc)(glass 2).Patients 4 times a day, after breakfast, lunch, dinner and before sleeping, first, wash their hands, cleaning teeth with a soft toothbrush and one type of toothpaste, then 15 cc of the solution kept for 3 min in their mouth and then throw away. Patients should not wash their mouth, and refrain from consuming food until one hour after.oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a oncology nurse who does not know the mouthwash solution and then checklist is completed.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The total potential data can be shared after unidentifiable people
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Only available to scholars working in academia and academia.
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Under which criteria data/document could be used
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If you observe the trust and mention the source, data is available for researchers.
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From where data/document is obtainable
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Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
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What processes are involved for a request to access data/document
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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.
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Comments
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