This study was a randomized, placebo- controlled trial to comparative effectiveness of Myrtus communis and Melissa officinalis essential oil plants in the treatment of minor aphtous mouth that main conditions entry to study:
1- More than four days since the beginning aphthous ulcers they not passed.
2- Before go for treatment of aphthous lesions are not using.
3- at the time of presentation of pain and irritation of the pest canker sores, which in the early days of Genesis is not diminished.
4- Patients must agree to cooperate with the project ( Moral satisfaction ).
Conditions of leaving study:
1- Another solution is to use the drug for the treatment of pests.
2- Not recommended to use the drug according to patient.
3- Not referring a patient for re- examination.
In this randomized double blind study with continuous sampling method, 137 patients with oral aphthous more than four days of aphthous ulcers had passed the order referred to in one of the group A ( solution containing 5 percent Myrtus communis and Melissa officialiss in ethanol 80 ° ) and B (solution containing 10 percent Myrtus communis and Melissa officialiss in ethanol 80 ° ) or c ( including placebo containing ethanol 80 ° ) groups And long recovery time, were examined daily by doctors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011205209N1
Registration date:2011-07-27, 1390/05/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-27, 1390/05/05
Registrant information
Name
Seyed Sina Eslami Raveshty
Name of organization / entity
Kimia drug pharmaceutical co
Country
Iran (Islamic Republic of)
Phone
+98 28 2289 7979
Email address
kimiadaru.pharmaceutical@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kimia drug pharmaceutical co
Expected recruitment start date
2010-04-07, 1389/01/18
Expected recruitment end date
2010-08-21, 1389/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness of Myrtus communis and Melissa officinalis essential oil plants in the treatment of minor aphthous mouth.
Public title
Effect of Myrtus communis and Melissa officinalis in pest treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Conditions of entry to study:
1- More than four days since the beginning aphthous ulcers they not passed.
2- Before go for treatment of aphthous lesions are not using.
3- at the time of presentation of pain and irritation of the pest canker sores, which in the early days of Genesis is not diminished.
4- Patients must agree to cooperate with the project ( Moral satisfaction ).
Conditions of leaving study:
1- Another solution is to use the drug for the treatment of pests.
2- Not recommended to use the drug according to patient.
3- Not referring a patient for re- examination.
Age
From 5 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
137
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
Kimia drug sina pharmaceutical co.
Street address
pouya complex Atarody Alley, Taleghani St, Imam komeini Blvd, Kimia drug sina pharmaceutical co
City
Abyek
Postal code
34979-34417
Approval date
2010-03-11, 1388/12/20
Ethics committee reference number
1208د/88
Health conditions studied
1
Description of health condition studied
mouth Diseases
ICD-10 code
C00.3 ,C00
ICD-10 code description
Upper lip, inner aspect & Lower lip, inner aspect
Primary outcomes
1
Description
Recovery time
Timepoint
Daily
Method of measurement
Doctor Examination
Secondary outcomes
1
Description
irritation and pain
Timepoint
Daily
Method of measurement
Doctor Examination
Intervention groups
1
Description
Drug intervention is a combination of two plant of Myrtus communis and Melissa officinalis essential oil containing 5 percent essential oil of Myrtus communis and Melissa officinalis in is 80 degrees ethanol and duration of intervention of course from day to see a complete healing of aphthous lesions, wich is a continuing and instructions of use the frequency consumption of to 5 to 6 tims a day, about 10 drops of liquid poured onto a small piece of cotton and the period of 20 to 30 seconds on hold and aphthous lesions.
Category
Treatment - Drugs
2
Description
Placebo as a intervention of includes ethanol 80 degrees.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital abyek city.
Full name of responsible person
Dr seyed bahaaldin Eslami Raveshty.
Street address
The first phase of gods town valiasr hospital.
City
Abyek
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kimia drug sina pharmaceutical co.
Full name of responsible person
Seyed Sina Eslami Raveshty.
Street address
pouya complex Atarody Alley, Taleghani St, Imam komeini Blvd, Kimia drug sina pharmaceutical co
City
Abyek
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kimia drug sina pharmaceutical co.
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
Kimia drug sina pharmaceutical co
Full name of responsible person
Seyed Sina Eslami Raveshty
Position
Engineering / kimia drug sina pharmaceutical co director of research and development
Other areas of specialty/work
Street address
pouya complex Atarody Alley, Taleghani St, Imam komeini Blvd, Kimia drug sina pharmaceutical co
City
Abyek
Postal code
34417-34979
Phone
+98 28 2289 7979
Fax
+98 28 2282 3500
Email
kimiadaru.pharmaceutical@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kimia drug sina pharmaceutical co
Full name of responsible person
Dr Seyed Bahaaldin Eslami Raveshty
Position
Doctor of pharmacy
Other areas of specialty/work
Street address
pouya complex Atarody Alley, Taleghani St, Imam komeini Blvd, Kimia drug sina pharmaceutical co
City
Abyek
Postal code
34417-34979
Phone
+98 28 2289 7979
Fax
+98 28 2282 3500
Email
kimiadaru.pharmaceutical@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
kimia drug sina pharmaceutical co
Full name of responsible person
Seyed Sina Eslami raveshty
Position
Engineering / Kimia drug sina director of research and development
Other areas of specialty/work
Street address
pouya complex Atarody Alley, Taleghani St, Imam komeini Blvd, Kimia drug sina pharmaceutical co
City
Abyek
Postal code
34417-34979
Phone
+98 28 2289 7979
Fax
+98 28 2282 3500
Email
kimiadaru.pharmaceutical@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)