Objective: The aim of this study is the evaluation of the effect of aqueous extract of scrophularia striata on mucositis in patients undergoing chemotherapy. Design: A randomized clinical trial . Setting:This study will be performed on two groups of 60 patients undergoing chemotherapy. Each group consist of 30 patients.Allocation of samples will be done by using simple random with table of random numbers.Intervention: In the intervention group, after the usual treatment (including mouthwash combination of nystatin drop, mucosamine spray, aluminum mgs syrup and diphenhydramine) after half an hour, a mouthwash will be done with aqueous extract of scrophularia striata. In control group half an hour after the usual treatment, mouthwash will be done with cold water. To determine the severity of mucositis, the mucositis intensity chart will be used. Inclusion criteria included having cancer; doing chemotherapy at least once; getting mucositis. Exclusion criteria included dissatisfaction with continued participation in research and death.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071725929N6
Registration date:2017-08-01, 1396/05/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aqueous extract of scrophularia striata on mucositis in patients undergoing chemotherapy: A randomized clinical trial
Public title
Effect of aqueous extract of scrophularia striata on mucositis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having cancer; doing chemotherapy at least once; getting mucositis
Exclusion criteria: Dissatisfaction with continued participation in research; death
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Sciences
Street address
Shahid Fahmideh Street, University of Medical Sciences, Hamadan
City
Hamedan
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.UMSHA.REC.1396.248
Health conditions studied
1
Description of health condition studied
mucositis
ICD-10 code
K12.3
ICD-10 code description
drug-inducedMucositis(oral) (oropharyngeal)
Primary outcomes
1
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Questionnaire VAS
Secondary outcomes
1
Description
Redness and inflammation of the mucus
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
In control group half an hour after the usual treatment, mouthwash will be done with cold water
Category
Treatment - Other
2
Description
In the intervention group after half an hour of the usual treatment of the hematology ward, mouthwash will be done with aqueous extract of scrophularia striata.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besaat Hospital
Full name of responsible person
Iraj Asadi
Street address
Shahid Fahmideh Street,Hamadan University of Medical Sciences, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Akram Mirzaei
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences, Hamedan
City
Hamedan
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 of Hamedan 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
Hamadan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
phd
Other areas of specialty/work
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 0717
Fax
Email
oshvandi2005@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
phd
Other areas of specialty/work
Street address
Shahid Fahmideh Street,Hamadan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3422 5056
Fax
Email
oshvandi2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master oh Science
Other areas of specialty/work
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)