The aim of this study is to assess the effect of Zataria multiflora extract mouthwash on radio-therapy induced oral mucositis. This Randomized double blind clinical trial is conducted on individuals newly diagnosed of head and cancers.
40 patients with radio-therapy treatment plan with at least 50 Gray exposure doses to oral filed according to the treatment protocol are entered in this study and divided into two equal numbered groups of extract and placebo.
Exclusion criteria are: allergy to Zataria multiflora, preexisting oral conditions, pregnancy , use of other medications related to oral mucositis during study period, any systemic diseases interfering with healing.
From one hour before radio-therapy, patients are given either placebo or 1% Zataria multiflora mouthwashes, three times daily after breakfast, lunch and dinner for 6 weeks.
Each time patients hold 5 ml of mouthwash in oral cavity for 2 minute and then spite it out. At the end of each week, oral mucositis intensity is measured by Oral Mucositis Assessment Scale (OMAS), which is based on the scores of erythema and ulcer in 9 areas of oral cavity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305285830N3
Registration date:2013-08-02, 1392/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-02, 1392/05/11
Registrant information
Name
Azar Aghamohammadi
Name of organization / entity
Islamic Azad University, Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 3179
Email address
azareaghamohamady@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of selective radioprotective effects of Zataria multiflora against oral mucositis induced by radiotherapy in cancer patients
Public title
Effects of Zataria multiflora against oral mucositis induced by radiotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria are: allergy to Zataria multiflora, preexisting oral conditions, pregnancy , use of other medications related to oral mucositis during study period, any systemic diseases interfering with healing.
Inclusion criteria: age older than 18 and less than 60 years; newly diagnosed of head and neck cancers; radio-therapy treatment plan with at least 50 Gray exposure doses to oral filed.
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
mazandaran university of medical science
Street address
Mazandaran university of medical science, Joybar 3 way, ImamSq, Sari, Iran
City
sari
Postal code
Approval date
2013-05-29, 1392/03/08
Ethics committee reference number
92-45
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Oral mucositis
Timepoint
Every week for 6 weeks
Method of measurement
Oral Mucositis Assessment Scale- OMAS
Secondary outcomes
1
Description
Pain
Timepoint
Every week for 6 weeks
Method of measurement
Visual analogue pain scale
Intervention groups
1
Description
From one hour before radio-therapy, patients are given 1% Zataria multiflora mouthwashes, three times daily after breakfast, lunch and dinner for 6 weeks.
Each time patients hold 5 ml of mouthwash in oral cavity for 2 minute and then spite it out.
Category
Treatment - Drugs
2
Description
From one hour before radio-therapy, patients are given placebo (mouthwashes without Zataria multiflora) , three times daily after breakfast, lunch and dinner for 6 weeks.
Each time patients hold 5 ml of mouthwash in oral cavity for 2 minute and then spite it out.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy centre of Shahid Rajaie hospital of Babolsar
Full name of responsible person
Azar Aghamohammadi
Street address
Sahid Rajaie hospital, next to Shilat, Shariatie Str, Babolsar Babol, Iran
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reasearch & Technology Deputy of Mazandaran medical science
Full name of responsible person
Ahmad Ali Enayati
Street address
Reasearch & Technology Deputy of Mazandaran medical science , Moalem squer , Sari , iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reasearch & Technology Deputy of Mazandaran medical science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Azar Aghamohammadi
Position
PhD student
Other areas of specialty/work
Street address
Mazandaran university of medical science, Joybar 3 way, ImamSq, Sari, Iran
City
Sari
Postal code
Phone
+98 15 1221 3014
Fax
Email
azareaghamohamady@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azar Aghamohammadi
Position
PhD student
Other areas of specialty/work
Street address
Mazandaran university of medical science, Joybar 3 way, ImamSq, Sari, Iran
City
Sari
Postal code
Phone
+98 15 1221 3014
Fax
Email
azareaghamohamady@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azar Aghamohammadi
Position
PhD by research student in traditional medicine
Other areas of specialty/work
Street address
Mazandaran university of medical science, Joybar 3 way, ImamSq, Sari, Iran
City
Sari
Postal code
Phone
+98 15 1326 7026
Fax
Email
azareaghamohamady@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)