The aim of present study was to investigate the effect of Calendula officinalis extract on radio-therapy induced oral mucositis. This non-randomized double blind clinical trial was conducted on individuals newly diagnosed of head and cancers. 40 patients with radio-therapy treatment plan with at least 40 Gray exposure doses to oral filed according to the treatment protocol and minimum age of 45 were selected and divided into two equal numbered groups of case and control. Each group of case and control was divided into two groups of male and female. Tumor sites were matched in all groups. Exclusion criteria were pregnancy, allergy to mouthwashes, preexisting oral conditions, use of other medications related to oral mucositis during study period, any systemic diseases interfering with healing. From onset of radio-therapy, patients were given either placebo or 2% Calendula mouthwashes, three times daily for 6 weeks. Each time patients held 5 ml of mouthwash in oral cavity for 1 minute and then spitted it out. At the end of each week, oral mucositis intensity was 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:IRCT201106076734N1
Registration date:2011-06-13, 1390/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-13, 1390/03/23
Registrant information
Name
Neda Babaee
Name of organization / entity
Department of oral diseases, Dental school of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4650
Email address
n.babaee@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research for Babol University of Medical Sciences
Expected recruitment start date
2008-02-20, 1386/12/01
Expected recruitment end date
2009-04-21, 1388/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Calendula officinalis extract on radiotherapy-induced oral mucositis
Public title
Investigation of Calendula officinalis extract on radiotherapy-induced oral mucositis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 1) Minimum accumulative dose of 40 Gy according to treatment protocol; 2) Complete exposure of oral field to x ray; 3) Minimum age of 45;
Exclusion criteria were: 1) Pregnancy; 2) Allergy to the mouthwash; 3) Preexisting oral conditions; 4) Use of other medications related to oral mucositis during study period; 5) Any systemic diseases interfering with healing
Age
From 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not 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
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz Str
City
Babol
Postal code
Approval date
2008-03-18, 1386/12/28
Ethics committee reference number
10124
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
Intensity of oral mucositis
Timepoint
at the end of each week for total of 6 weeks for each patient
Method of measurement
Oral Mucositis Assessment Scale (OMAS)
Secondary outcomes
empty
Intervention groups
1
Description
A gel which was equalized in taste, odor, shape and color to 2% Calendula mouthwash was used as a placebo mouthwash. Patients were instructed to use the mouthwash 3 three times daily from onset of radio-therapy for 6 week duration. Each time patients held 5 ml of mouthwash in their oral cavity for 1 minute.
Category
Placebo
2
Description
Herbal extract of plant Calendula officinalis was added to a basic gel to make 2% calendula mouthwash. Patients were instructed to use the mouthwash 3 three times daily from onset of radio-therapy for 6 week duration, each time patients held 5 ml of mouthwash in their oral cavity for 1 minute and then spitted it out.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy centre of Shahid Rajaie hospital of Babolsar
Full name of responsible person
Neda Babaee
Street address
Sahid Rajaie hospital, next to Shilat, Shariatie Str, Babolsar
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Babol University of Medical Sciences
City
Babol
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, Babol 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
Department of oral diseases, Dental School of Babol University of Medical Sciences
Full name of responsible person
Neda Babaee
Position
Assistant professor, DDS, MS
Other areas of specialty/work
Street address
Department of oral diseases, Dental School of Babol University of Medical Sciences, Felestin Str, Velayat Square
City
Babol
Postal code
Phone
+98 11122914089
Fax
Email
n.babaee@mubabol.ac.ir; dr_nedababaee@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of oral diseases, Dental School of Babol University of Medical Sciences
Full name of responsible person
Neda Babaee
Position
Assistant professor, DDS, MS
Other areas of specialty/work
Street address
Department of oral diseases, Dental School of Babol University of Medical Sciences, Felestin Str, Velayat square
City
Babol
Postal code
853
Phone
+98 11122914089
Fax
Email
n.babaee@mubabol.ac.ir; dr_nedababaee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of oral diseases, Dental School of Babol University of Medical Sciences
Full name of responsible person
Neda Babaee
Position
Assistant professor, DDS, MS
Other areas of specialty/work
Street address
Department of oral diseases, Dental School of Babol University of Medical Sciences, Felestin Str, Velayat square
City
Babol
Postal code
Phone
+98 11122914089
Fax
Email
n.babaee@mubabol.ac.ir; dr_nedababaee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)