Background and the Purpose of the Study: stomatitis is a disturbing and prevalent side-effect of chemotherapy that disturbs patients and causes difficulties in patient’s drinking, eating and talking, and may results in infection and bleeding and eventually decrease quality of life .This study aimed to investigate the effect of the marshmallow root extract on treatment of Stomatitis due chemotherapy. Materials and Methods: This randomized controlled trial study was conducted during 2016.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. In this study, 50 patients diagnosed with cancer that undergoing chemoterapy were randomly assigned into control and experimental groups in similar blocks according to their stomatitis severity. In this study; patient, the nurse that examined mouth the patient and give mouthwash solution to the patient were not aware from the content of the solutions. Severity of stomatitis in experimental and control groups is similar.Inclusion criteria:undergoing chemotherapy; age above18 years old;having consciousness; consent for participation in the study; no history of underlying disease (allergy, allergic rhinitis, asthma ) and hypersensitivity and immune system illness; no use another mouthwash solution during the study;do not receive systemic antibiotic or anti fungi agents; not doing radiotherapy during treatment; lack of sensitivity to plants. Exclusion criteria: receiving radiotherapy during treatment; use from another solution mouthwash during the study; the decision to withdraw from the study; irregular use of mouthwash solution (frequency, amount:No mouthwash more than once a day or more than 10 times a week Also,if the volume of the solution used in the mouthwash every time is be less than 10cc); sensitivity to plants and received systemic antibiotics and anti fungi agents at the beginning or during the study. 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).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 mouth wash.Oral mucosa of patients and pain mouth of them on the first,seventh and fourteenth days after getting mouthwash checked by researcher or oncology nurse who does not know the mouthwash solution and then stomatitis and stomatiotis induced mouth pain checklist is completed.
General information
Acronym
Marshmallow root and ostomatitis
IRCT registration information
IRCT registration number:IRCT201307274655N4
Registration date:2016-07-14, 1395/04/24
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-07-14, 1395/04/24
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
Kashan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mouthwash solution contaning marshmallow root extract and routine solution on improvement chemotherapy induced stomatitis
Public title
Effect of mouth wash contaning marshmallow root extract on improvement stomatitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: undergoing chemotherapy; age above18 years old; having consciousness; consent for participation in the study; no history of underlying disease (allergy, allergic rhinitis, asthma ) and hypersensitivity and immune system illness;; no use another mouthwash solution during the study; do not receive systemic antibiotic or anti fungi agents; not doing radiotherapy during treatment; lack of sensitivity to plants.
Exclusion criteria: receiving radiotherapy during treatment; use from another solution mouthwash during the study; the decision to withdraw from the study; irregular use of mouthwash solution (frequency, amount:No mouthwash more than once a day or more than 10 times a week Also,if the volume of the solution used in the mouthwash every time is less than 10cc); sensitivity to plants and received systemic antibiotics and anti fungi agents at the beginning or during the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
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.
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- Ghotb Ravandi Blvd
City
Kashan
Postal code
87159/81151
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.KAUMS.REC.1395.10
Health conditions studied
1
Description of health condition studied
Stomstitis
ICD-10 code
K12.1
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
ostomatitis
Timepoint
Before and seventh and fourteenth days after the intervention
Method of measurement
Standardized checklist stomatitis WHO
Secondary outcomes
1
Description
Change grade of stomatitis
Timepoint
Beforebefore and seventh and fourteenth days after the intervention
Method of measurement
Standardized checklist stomatitis WHO
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
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
Taghadsi Mohsen
Street address
Kashan University of Medical Sciences -Arctic Blvd Ravandi -
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Vice President of Research of Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD -director of journal pheyz Department,Head of medical-surgical group
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Web page address
www.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD of nursing - director of journal pheyz Department, director of medical surgical group
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
Taghadosi_m@kaums.ac.ir
Web page address
www.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
ghorbani vadeghani Mohamadsadegh
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
g.mohamadsadegh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)