The aim of this study is to evaluate the effect of Propolis mouthwash to prevent mucoitis caused by chemotherapy. This randomized clinical trial conducted among 40 adult patients (20-60 years) who referred to Hematology and Oncology Department of the Shahid Sadoughi Hospital for chemotherapy and at first courses developed mucoitis. Patients randomly assigned to intervention and control groups (placebo) each containing 20 patients. Propolis mouthwash in the intervention group (Mashhad Tak Toos Soren Co, 30% extracts) and the placebo control group (Mashhad Tak Toos Soren Co, Water and Additives) 24 hours before the onset of the second course of chemotherapy for 3 times per day every 8 hours for 14 days after completion of the course. At the 7th and 14th days the patient's mouth examined in a light and their ability to eat and drink recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022924959N2
Registration date:2016-03-18, 1394/12/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-18, 1394/12/28
Registrant information
Name
Maryam Kheirandish
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 9104
Email address
dr.hashemi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Propolis Mouthwash in the Prevention of the Chemotherapy Induced Mucositis
Public title
Evaluation of the Effect of Propolis Mouthwash in the Prevention of Mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Adults aged 20-60 years old; patients referred to the Hematology and Oncology Department of the Shahid Sadoughi Hospital for chemotherapy and at first courses developed mucositis.
Exclusion criteria: Outside the specified age range; sensitivity to Propolis mouthwash; the worsening condition of the patient
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Vice Chancellor for Research, Headquarter of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Postal code
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
Ssu. 176/3456
Health conditions studied
1
Description of health condition studied
mucositis
ICD-10 code
K12.0
ICD-10 code description
K12.3
Primary outcomes
1
Description
Ability to eat and drink
Timepoint
Seventh and fourteenth days
Method of measurement
Ask from the Patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mouthwash Propolis (Mashhad Tak Toos Soren Co, 30% extracts)
Control group: Placebo (Mashhad Tak Toos Soren Co, Water and Additives)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology and Oncology Department, Shahid Sadoughi Hospital
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Amir Houshang Mehrparvar
Street address
Vice Chancellor for Research, Headquarter of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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 Sadoughi University of Medical Sciences
Full name of responsible person
Maryam Jalili Sadr Abad
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3822 9104
Fax
Email
hn_1364@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Karbasi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
+98 35 3726 3733
Fax
Email
dr.njalili@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Hossein Neamatzadeh
Position
Other areas of specialty/work
Street address
Hematology and Oncology Research Center, Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 3822 9104
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)