(1)Objectives: Studying the effect of various concentrations of Myrtels essence in treatment of oral mucus aphthous ulcers.(2) Design: 60 patients with oral mucus pathos who are divided randomly into two 30fold groups based on randomization numbers table are participated in this study.The approach of this study is double-blind approach and in trail phases 2 and 3. (3) Setting and conduct; First, the patients' specifications and also their aphthous ulcers size and their pain value are recorded.
(4) Participants:The participants should not use other medicine before participating in the study and in case of consumption other medicine (drug) together with the advised solution will be excluded from the study. (5) Interventions: then a patients group is given 5% Myrtus solution and another group is given 2.5% Myrtus solution made in Kashan Barij Essence (Mirtex). Myrtus essence must be consumed by this way that the patients should pour 10 drops of the medicine on small cotton and put it for 20 seconds on aphthous ulcers 5 times per day this work shall be continued for 7 days.(6) Main outcome measures: After each consumption period, the patients' injury information included the injury size would be measured by putting a transparent paper (mm), injury irritation size can be measured by VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015053020903N2
Registration date:2015-09-08, 1394/06/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
zahra Roustaeizade Shouroki
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5884
Email address
dr.roustaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Yazd University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of different myrtle extract concentrations on treatment of oral mucous aphthous ulcers.
Public title
the effect of different myrtle extract on oral aphthous ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :people who are diagnosed clinical oral aphthous; do not have any systemic disease; infection with HIV; anemia; The patient's age most be between 20-40 years.
Exclusion criteria: patients who are Challenge taking the drug; not present at the examination session .
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
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
Not used
Assignment
Parallel
Other design features
Randomization According to Table of random numbers
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid sadoughi Boulvar، Yazd
City
Yazd
Postal code
Approval date
2015-01-20, 1393/10/30
Ethics committee reference number
223594
Health conditions studied
1
Description of health condition studied
Recurrent oral aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent aphthous ulcer
Primary outcomes
1
Description
size of lesion
Timepoint
befor Intervention، one day after Intervention، seven days after Intervention.
Method of measurement
transparet milimeteric paper
2
Description
pain and irritation
Timepoint
befor Intervention، one day after Intervention، seven days after Intervention.
Method of measurement
visual analog scale(vas)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
using the 5% myrtle solution made by
Baryj Essence Pharmaceutical Co. Kashan(
Myrtex)The patients were instructed to apply 10 drops of 5% myrtle solution on a small piece of cotton and keep it on the lesion for 20 seconds and do it 5 times a day for 7 days
Category
Treatment - Drugs
2
Description
using the2.5%(
Diluted by ethanol) myrtle solution made by
Baryj Essence Pharmaceutical Co. Kashan(
Myrtex)The patients were instructed to apply 10 drops of 5% myrtle solution on a small piece of cotton and keep it on the lesion for 20 seconds and do it 5 times a day for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
College Dentistery of Yazd
Full name of responsible person
Ehsan Babaei Zarch
Street address
College Dentistery of Yazd،Dahe Fajr Boulevard،Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Ghezry
Street address
College Dentistery of Yazd،Dahe Fajr Boulevard،Yazd
City
Yazd
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,Yazd 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 and Health Services
Full name of responsible person
Zahra Roustaeizadeh
Position
Assistant Professor of oral medicine
Other areas of specialty/work
Street address
College Dentistery of Yazd،Dahe Fajr Boulevard،Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
esi.ebz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
zahra roustaei zadeh
Position
Assistant Professor of oral medicine
Other areas of specialty/work
Street address
College Dentistery of Yazd،Dahe Fajr Boulevard،Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
esi.ebz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Zahra Roustaeizadeh
Position
Assistant Professor of oral medicine
Other areas of specialty/work
Street address
College Dentistery of Yazd،Dahe Fajr Boulevard،Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
esi.ebz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)