Objective:This single-blind clinical trial of the experimental and control groups with the aim of determine the effect of aqueous extract of sage on Preventing Stomatitis in children with Leukemia that admitted to the Hospital Besat Hematology Chemotherapy Unit in 1396. In this study, 54 patients with Cancer receiving chemotherapy were enrolled and randomly method available in any of the treatment groups (Rinse with water extract of sage) and control (Normal saline Mouthwash) are placed.
In the control group patients only recived routine treatment for patients with Stomatitis and in the experimental group used the routine treatment for mouth rinse in addition to 3 drops of extract in 2 ml water, diluted, enter the patient's mouth after brushing their teeth and mouth are rotated in and out for 1 minute and until 1hour did not eat anything. To measure the effects of saline and aqueous extracts of sage on the severity of stomatitis use of the World Health Organization standard tools.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011732025N1
Registration date:2017-02-10, 1395/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Arash Khalili
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
a.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials the effect of aqueous extract of salvia officinalis for Preventing Stomatitis in Children With leukemia Undergoing Chemotherapy
Public title
The effect of aqueous extract of salvia officinalis for Preventing Stomatitis in Children With leukemia Undergoing Chemotherapy In Besat hospital.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:The age of 6 to 14 years; Children's be admitted in Hematology Hospital Besat; children is leukemia; child or caregiver and are now teaching the Persian language; baby have at least once chemotherapy and for the prevention of stomatitis to be hospitalized by doctor; Lack of sensitivity to drug sage Exclusion criteria: lack of desire to continue to participate in the study; out of the study for any reason during the study, such as death, relocation and ....
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University Of Medical Scinces
Street address
Hamadan University Of Medical Scinces, Shahid Fahmideh Boulvard, Hamadan, Iran.
City
Hamadan
Postal code
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.UMSHA.REC.1395.450
Health conditions studied
1
Description of health condition studied
ALL
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]
Primary outcomes
1
Description
Stomatitis
Timepoint
1week
Method of measurement
Oral Mucositis Assessment Scale
Secondary outcomes
1
Description
Oral Wound
Timepoint
1 Week
Method of measurement
Oral Mucositis Assessment Scale
Intervention groups
1
Description
This randomized, double-blind study, with a test group and a control group hematology hospital in Besat enforced. 60 leukemia patients undergoing chemotherapy simple random way in each of the treatment groups (rinse with water extract of sage and cocktails solution of 30 patients) and control (rinse with a solution of cocktails, 30) are placed.
in the experimental group used the routine treatment for mouth rinse in addition to 3 drops of extract in 2 ml water, diluted, enter the patient's mouth after brushing their teeth and mouth are rotated in and out for 1 minute and until 1hour did not eat anything.
Category
Prevention
2
Description
In the control group patients only recived routine treatment for patients with Stomatitis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hamadan Hospital
Full name of responsible person
Fariba Ebrahimi
Street address
Hamadan, Besat Hamadan Hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University Of Medical Scinces
Full name of responsible person
Fariba Ebrahimi Horyat
Street address
Hamadan University Of Medical Scinces
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University Of Medical Scinces
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
Hamadan University Of Medical Scinces
Full name of responsible person
Fariba Ebrahimi Horyat
Position
Master Nursing Student
Other areas of specialty/work
Street address
Hamadan University Of Medical Scinces
City
Hamadan
Postal code
Phone
+98 818380320
Fax
Email
abrahymyfryba94@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Scinces
Full name of responsible person
Dr Khodayar Oshvandi
Position
Nursing PHD
Other areas of specialty/work
Street address
Hamadan University Of Medical Scinces
City
Hamadan
Postal code
Phone
+98 818380320
Fax
Email
oshvandi2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University Of Medical Scinces
Full name of responsible person
Arash Khalili
Position
Master Of Nursing
Other areas of specialty/work
Street address
Hamadan University Of Medical Scinces
City
Hamadan
Postal code
Phone
+98 81 3422 5650
Fax
Email
arash5920@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)