The goal of this randomized clinical trial is evaluation the effect of propolis solution on prevention and treatment of oral mucositis in patients undergoing the first episode of head and neck radiotherapy . This study is a randomized , double-blind and placebo- control. 60 patient who are referred to Imam Hossein Hospital for radiation therapy were randomly placed in two groups of 30 people (intervention and control group). The first group of patients will receive 5 drops of propolis solutionTDS (16 mg TDS ) for one month.The second group will received placebo. All patients will visit and evaluate weekly by radiotherapist and oral mucositits will record according to WHO, OMAS and NCI indices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010225726N2
Registration date:2016-05-18, 1395/02/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmacy School of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of propolis solution on prevention and treatment of oral mucositis in patients undergoing head and neck radiotherapy.
Public title
Effect of propolis solution on prevention and treatment of oral mucositis in patients undergoing head and neck radiotherapy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing the first episode of head and neck radiotherapy without any oral mucositis.Exclusion criteria: Chronic liver failure (Stage II & III); Chronic kidney disease (Stage IV & V); oral active infection; active collagen vascular disease; presence of any type of allergy and sensitivity to honey and propolis.
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Tehran,Valiasr Street intersection of Niayesh Highway
City
Tehran
Postal code
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.SBMU.PHNM.1394.309
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K12.3
ICD-10 code description
موکوزیت دهانی ناشی از رادیوتراپی
Primary outcomes
1
Description
Mucositis severity
Timepoint
weekly
Method of measurement
Based on the criteria of NCI, OMAS & WHO
Secondary outcomes
1
Description
Pain
Timepoint
Once a week for a month
Method of measurement
Based on the pain scale grade classification(0-10)
2
Description
Dysphagia
Timepoint
Once a week for a month
Method of measurement
Clinical evaluation and Questionnaire
Intervention groups
1
Description
Intervention: administration of propolis , oral solution ,5 dropsTDS(16mg TDS), duration of intervention is one month
Category
Prevention
2
Description
Control group receives placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Street address
Tehran,Shahid madani street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Street address
Tehran-Valiasr Street intersection Niayesh Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samaneh Dodge
Position
PharmD. Student of Pharmacy
Other areas of specialty/work
Street address
Tehran,Valiasr Street intersection of Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0118
Fax
Email
samaneh.dodge1992@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Behesti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant professor, Clinical pharmacy specialist
Other areas of specialty/work
Street address
Tehran,Valiasr Street intersection of Niayesh Highway