Protocol summary

Summary
The purpose of this study is to investigate the effect of mouth wash containing yarrow plant extract on improvement stomatitis due chemotherapy. Double blind clinical trial study is conducted in cancer patients admitted to Shaheed Beheshti Hospital with oral stomatitis and under chemotherapy treatment with an anti-inflammatory drugs. In this study; patient, the nurse examined mouth the patient and give mouthwash solution to the patient were not aware from the content of the solution. Inclusion criteria: informed consent for participation in the study, aged 20 years and older, not receive radiation therapy after diagnosis, not use another mouthwash solution during the study, not receiving systemic antibiotics and antifungals. In this study participants will exclude if they are using irregular (amount, frequency) mouthwash and they cannot tolerate the smell of a solution containing yarrow extract. In this study, 42 patients were selected by convenience sampling with table of random numbers; severity of stomatitis in experimental and control groups is similar. To all patients after admission, are given extract yarrow+ routine solution (glass 1 (experimental)) and the routine solution (lidocaine , dexamethasone, sucralfate, diphenhydramine) (glass 2(control)). 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. According to a double blind study, oral mucosa patients on the first, seventh and fourteenth days after getting mouthwash checked by a nurse working in oncology ward who does not know the mouthwash solution and then checklist is completed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092214729N1
Registration date: 2013-12-31, 1392/10/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-31, 1392/10/10
Registrant information
Name
Leyla Soleymanpoor
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33 4635 2622
Email address
miranzadeh_s@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-10-01, 1392/07/09
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mouth wash containing yarrow plant extract and routine solution on improvement stomatitis in cancer patients receiving chemotherapy
Public title
Effect of mouth wash containing yarrow plant extract on improvement stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent for participation in the study, aged 20 years and older, no underlying disease (allergy, allergic rhinitis, asthma ), not receive radiation therapy after diagnosis, having consciousness, not use another mouthwash solution during the study, and not receiving systemic antibiotics and antifungals. Exclusion criteria: receiving radiotherapy during treatment, fever, use from another solution mouthwash during the study, the decision to withdraw from the study, irregular use of mouthwash solution (frequency, amount), solution containing extract yarrow odor intolerance by patients and received systemic antibiotics and antifungals at the beginning or during the study.
Age
From 1 year old to 149 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 42
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 (glass 1: extract yarrow + 2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2% and glass 2: 2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) . 1) The person who gave the glass to the patient 2) A person who has examined the oral mucosa. 3) Patients

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd
City
Kashan
Postal code
88141/87159
Approval date
2013-09-30, 1392/07/08
Ethics committee reference number
2571/1/5/29/پ

Health conditions studied

1

Description of health condition studied
Stomatitis
ICD-10 code
k12.1
ICD-10 code description
Stomatitis and related lesions

Primary outcomes

1

Description
Stomatitis
Timepoint
Before and seventh and fourteenth days after the intervention
Method of measurement
Standardized checklist stomatitis WHO

Secondary outcomes

empty

Intervention groups

1

Description
Case 1: a experimental group solution containing extract yarrow-routine solution (2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) (glass 1) is given will. 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. According to a triple blind study, 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
Case 2: a control group routine solution containing (2 dexamethasone 8 mg, 5 tablets sucralfate 500 mg, 1 syrup diphenhydramine 12.5 mg, 1 injection of lidocaine 2%) (glass 2) is given will. 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. According to a triple blind study, 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
Shaheed Beheshti Hospital of Kashan University of Medical Sciences
Full name of responsible person
Leyla Soleymanpoor
Street address
Kashan University of Medical Sciences
City
Kashan

2

Recruitment center
Name of recruitment center
Shaheed Beheshti Hospital of Kashan
Full name of responsible person
Sedigheh Miranzadeh
Street address
Nursing Faculty, Kashan University of Medical Sciences
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholam ali Hamidi, Vice chancellor for research, Kashan University of Medical Sciences
Street address
Vice chancellor for research, 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
Vice chancellor for research, 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
Kashan University of Medical Sciences
Full name of responsible person
Leyla Soleymanpoor
Position
Graduate student
Other areas of specialty/work
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
87155/111
Phone
+98 33 4635 2622
Fax
Email
Leylalegla@yahoo.com
Web page address
www.kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sedigheh Miranzadeh
Position
Master of Science
Other areas of specialty/work
Street address
Kashan - Ghotb Ravandi Blvd.
City
Kashan
Postal code
81755/111
Phone
+98 36 1555 2999
Fax
Email
S_Miranzadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Leyla Soleymanpoor
Position
Graduate student
Other areas of specialty/work
Street address
Kashan - Ghotb Ravandi Blvd.
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 2999
Fax
Email
Leylalegla@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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