Protocol summary

Summary
Objectives: Evaluation effect of topical 6.3.3 penicillin powder in the treatment of oral aphthous ulcer. Design: Penicillin and placebo powder put in the same pockets, then coded based on random numbers table and given to Patients. Setting and conduct: After comments and complete the consent form by volunteers, powder four times (one hour after meals and before bed) is used and by an applicator is placed on a wound as a single layer. Patients examine in days zero, three, six and eight the followings: A) Pain, including Mild: Can you eat food, moderate: be able to eat more than half the food, Severe: Can not eat more than half of food. B) Wound size: The largest and smallest lesion diameter was measured with a caliper, multiply and is used to evaluate the wound. C) Complications: Burning, pain, erythematic, inflammation. Participants including major eligibility: Persons 15-45 years with a history of aphthous stomatitist and oral mucosa is easily accessible location. People with a history of penicillin allergy ،cephalosporin and beta-lacteal antibiotics or ulcer were healing less than five days were excluded from the study. Interventions: 6.3.3 penicillin powder and placebo, as a topical applicator (0.2 mg) Outcome variables: size reduction, pain relief, reduction of oral aphthous improvement, complications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106102154N2
Registration date: 2012-11-05, 1391/08/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-05, 1391/08/15
Registrant information
Name
Mohammad Bagher Owlia
Name of organization / entity
Sadoughi University
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4000
Email address
owlia@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University Of Medical Sciences ,Yazd
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparative topical penicillin 6.3.3 powder and placebo in the treatment of patients 15 -45 years old with aphtous ulcer of mouth.
Public title
Evaluation of topical penicillin 6.3.3 Powder in treatment of Oral aphthous ulceration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15-45 years; history of oral aphthous; available sites; such as cheek mucosa, floor of mouth, lips and tongue is; attend and complete a consent form. Exclusion criteria: history of allergy to penicillin & cephalosporin or antibiotics beta Latham, improve spontaneously of ulcer less than 5 days, debilitating disease such as active tuberculosis or HIV; tobacco or alcohol abuse; Pregnancy; more than 5 ulcer in mouth; improve of ulcer less than 5 days.
Age
From 15 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
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 Shahid Sadoughi University of Medical Sciences
Street address
Pardis Unit, Safaiea, Yazd
City
Yazd
Postal code
8916884566
Approval date
2011-02-21, 1389/12/02
Ethics committee reference number
126962

Health conditions studied

1

Description of health condition studied
Recurrent oral aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae

Primary outcomes

1

Description
Aphtous size
Timepoint
Days of zero, 3, 6, 8
Method of measurement
The largest and smallest lesion diameter was measured with a small ruler, multiply and is used to evaluate the wound.

2

Description
Pain
Timepoint
Days of zero, 3 , 6 , 8
Method of measurement
Mild: Can you eat food, moderate: be able to eat more than half the food, Severe: Can not eat more than half of food.

3

Description
Complications
Timepoint
Days of zero, 3, 6, 8
Method of measurement
Examination: Burning, pain, erythematic, inflammation

4

Description
Recovery period
Timepoint
Days of zero, 3, 6, 8
Method of measurement
Reduction of size and pain

Secondary outcomes

empty

Intervention groups

1

Description
Drug: 0.2 mg Penicillin 6.3.3 powder, locally, with applicator, four times
Category
Treatment - Drugs

2

Description
Placebo: 0.2 mg fiber clear powder, locally, with applicator, four times
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Dr Mohammad Bagher Owlia, Rheumatologist, Associate Professor
Street address
Safaiea, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Ezzoddini.
Street address
Vice chancellor for research, Shahid Sadoughi University Of Medical Sciences, Third Floor, Central Organization Of Medical Sciences, Bahonar Square, 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 of Shahid Sadoughi 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 Hospital, Shahid Sadoughi University Of Medical Sciences
Full name of responsible person
Mahboobah Mirzadeh
Position
Internal Resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Safaie, Yazd
City
Yazd
Postal code
8916884566
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
dr mmirzadeh@ gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi Hospital, Shahid Sadoughi University
Full name of responsible person
Mohammad Bagher Owlia
Position
MD, Rheumatologist, Associate Professor of Medicine
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Safaie, Yazd
City
Yazd
Postal code
8916884566
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
owlia@ ssu.ic.ir
Web page address
www// mbowlia.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mahboobah Mirzadeh
Position
Internal Resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospitall, Safaie, Yazd
City
Yazd
Postal code
8916884566
Phone
+98 35182240004
Fax
+98 35 1822 4100
Email
dr mmirzadeh@ gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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