The objective of this study is to compare the treatment effect of Curcumin orabase and Triamcinolon acetonide orabase on the oral GVHD that is done on 26 patients. The following patients will be excluded from the study: having another medication within 3 month prior to the study. Patient in intervention group and control group will receive Curcumin and triamcinolon acetonid orabase respectively, for 4 weeks and will be followed up for 2 months. The primary outcomes are size of lesion and Visual Analogue Scale.
General information
Acronym
Graft-versus-host reaction or disease
IRCT registration information
IRCT registration number:IRCT201508173144N5
Registration date:2016-06-09, 1395/03/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-09, 1395/03/20
Registrant information
Name
Arash Mansourian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 1833 8400
Email address
amansourian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-09-11, 1394/06/20
Expected recruitment end date
2015-11-11, 1394/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisian of local treatment by triamcinolon orabase with curcumin orabase in oral GVHD
Public title
Comparisian of local treatment by triamcinolon orabase with curcumin orabase in oral Graft-versus-host reaction or disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being a patient with Oral Graft-versus-host reaction or disease. Exclusion criteria: taking another medication.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Tehran University of Medical Sciences
Street address
Vice chancellor for research of Tehran University of Medical Sciences, Qhods street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-11-28, 1394/09/07
Ethics committee reference number
IR.TUMS.REC.1394.1300
Health conditions studied
1
Description of health condition studied
Graft-versus-host reaction or disease
ICD-10 code
T86.0
ICD-10 code description
Graft-versus-host reaction or disease
Primary outcomes
1
Description
Ulcer pain
Timepoint
One week after intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Ulcer size
Timepoint
One week after intervention
Method of measurement
Kolis
Secondary outcomes
1
Description
Ulcer healing
Timepoint
One week after intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group1: triamcinolone paste, QID, for 30 min, for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Curcumin paste, QID, for 30 min for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Shahabodin Babaei Fard
Street address
Shariati Hospital, North Karegar street, Jalal-e-Ahmad st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Akhoondi
Street address
Research Center of Dental sciences, NO 20, Ghods street, Enghelab street.
City
Tehran
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, Faculty of Dentistry, Tehran 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
Dental Faculty, Tehran University of Medical Sciences
Full name of responsible person
Shahabodin Babaei Fard
Position
Post graduate student of oral and maxillofacial medicine
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental Faculty, Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 21 8835 1152
Fax
+98 21 6640 1132
Email
dr.babaeifard@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Mansourian
Position
Oral and maxillofacial Medicine Board
Other areas of specialty/work
Street address
Dental faculty of Tehran university of medical sciences, North karegar street
City
Tehran
Postal code
1439955991
Phone
+98 22 1833 8400
Fax
+98 21 6640 1132
Email
amansourian@tums.ac.ir
Web page address
amansourian@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty, Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Sadat Moosavi
Position
Oral & Maxillofacial Medicine Board
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty, Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 21 8801 5800
Fax
+98 21 6640 1132
Email
amansourian@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)