The comparison effect of a herbal drug (Golnar) and triamcinolon acetonide on healing ulcer in Recurrent aphthous stomatitis patients (clinical trial study)
In this double-blind clinical Trial study, 60 patients with minor aphthous ulcer which no medicine used and no systemic disease were enrolled in study. The aim of this study was evaluation of therapeutic effect of Golnar gel on minor aphthous ulcer and comparison with Triadent. Patients were divided randomly into three groups of Golnar, Triadent and Placebo as the form of each three type of medicine was similar completely and was coded A,B ,C by the third person. every time one of coded medicine was given to the patients randomly. nor clinician nor patients didn’t understand type of medicine. The gel applied three times a day by patients. The pain intensity was evaluated by VAS. More ever in recall examination that was done by clinician , size of ulcer and healing time of ulcer was recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606063251N6
Registration date:2017-01-25, 1395/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Atefeh Tavangar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2814
Email address
tavangar@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental
Expected recruitment start date
2015-06-10, 1394/03/20
Expected recruitment end date
2016-08-03, 1395/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of a herbal drug (Golnar) and triamcinolon acetonide on healing ulcer in Recurrent aphthous stomatitis patients (clinical trial study)
Public title
efficacy of golnar on aphthous ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 24 to 48 initial hours of wound; history of recurrent ulcer; no drug has used; no systemic disease
exclusive criteria: major and herpetiform aphthous; systemic disease; antibiotic drug using and any type of cortocosteroid medicine
Age
No age limit
Gender
Both
Phase
2
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
Ethics committee of Isfahan University of Medical Siences
Street address
Isfahan University of Medical Siences, Darvazeh Shiraz
City
Isfahan
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.MUI.EC.1394.3.1027
Health conditions studied
1
Description of health condition studied
Aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Size of wound
Timepoint
first, third, and fifth day after intervention
Method of measurement
ruler
2
Description
pain
Timepoint
Before study ,first, third, and fifth day after onset of study
Method of measurement
VAS scale
3
Description
Healing ulcer
Timepoint
before onset of study and after end of the study
Method of measurement
examination
Secondary outcomes
empty
Intervention groups
1
Description
Triadent orabase , thrice a day ,until complete remission of aphthous ulcer, Raha Pharmaceutical Co
Category
Treatment - Drugs
2
Description
Placebo , thrice a day , until complete remission of ulcers, School of Phamacy, Isfahan university of Medical Science
Category
Placebo
3
Description
Golnar orabase. thrice a day , until complete remission of ulcers, School of Phamacy, Isfahan university of Medical Science
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ِDentistry school of Isfahan university of medical science
Full name of responsible person
Atefeh tavangar
Street address
Hezar jerib S, Isfahan university of medical science
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chanceller for research, Isfahan University of Medical Siences
Full name of responsible person
Omid Savabi
Street address
Hezar jerib S, Isfahan University of Medical Siences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chanceller for research, Isfahan University of Medical Siences
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
Isfahan university of medical science
Full name of responsible person
Atefeh Tavangar
Position
Assistant Proffessor
Other areas of specialty/work
Street address
Hezar jerib S, Isfahan University of Medical Siences
City
Isfahan
Postal code
81746-73461
Phone
+98 3133792551415
Fax
Email
tavangar@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of Medical science
Full name of responsible person
Atefeh Tavangar
Position
Specialist in Oral & Maxillofacial Medicine
Other areas of specialty/work
Street address
Dentistry school of Isfahan University of Medical Siences
City
Isfahan
Postal code
Phone
+98 313792551415
Fax
Email
tavangar@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Siences
Full name of responsible person
Atefeh Tavangar
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar jerib S, Isfahan University of Medical Siences
City
Isfahan
Postal code
81746-73461
Phone
+98 313792551415
Fax
+98 31 3668 7080
Email
tavangar@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)