A blind clinical trial for efficacy evaluation of a topical burn ointment consisting of Sesame oil, Zinc Oxide and Camphor in burn treatment of 1 and 2 degrees
The aim of the study was the efficacy evaluation of a topical burn ointment, consists of Camphor, Zinc Oxide and Sesame oil versus traditional burn treatment in outpatient setting. 60 burn patients of 1 and 2 degrees, eligible to enter the study were randomly assigned into "case" and "control" . Treatment in case group included burn lesion irrigation, debridement, if necessary and dressing using the topical Burn ointment. On the other hand, patients in control group were treated by irrigation, debridement, if necessary and dressing using vaseline guaze as well as orally administered acetaminophen. The patients were visited at least 3 times in the first week. The primary aims of the study were to compare pain, blister formation and burn lesion secretion among the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011312107N1
Registration date:2013-03-10, 1391/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-10, 1391/12/20
Registrant information
Name
Mohammad Reza Saberi
Name of organization / entity
School of Pharmacy, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
saberimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Morvarid Co. (private)
Expected recruitment start date
2005-04-21, 1384/02/01
Expected recruitment end date
2005-09-23, 1384/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A blind clinical trial for efficacy evaluation of a topical burn ointment consisting of Sesame oil, Zinc Oxide and Camphor in burn treatment of 1 and 2 degrees
Public title
Study of the efficacy of a topical burn ointment dressing versus traditional Vaseline gauze dressing in burn treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: burn lesions of 1 and 2 degrees, based on clinical examination, occured not more than 6 hours before randomization.
Exclusion criteria: unwillingness to enter the study; being a candidate for inpatient treatment; need to antibiotics; suffering diabetes mellitus or renal failure; using immune suppressors and if she is pregnant.
Age
From 1 year old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmacy School of Mashhad University of Medical Sciences
Street address
P. O. Box 91775-1365, Mashhad
City
Mashad
Postal code
Approval date
2005-04-14, 1384/01/25
Ethics committee reference number
828/A/40
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20-25
ICD-10 code description
Burns and corrosions of external body surface, specified by site
Primary outcomes
1
Description
Pain
Timepoint
One hours after treatment
Method of measurement
Questionnaire
2
Description
Blister formation
Timepoint
The begining of the study, first prescription, second prescription
Method of measurement
Objective
3
Description
Burn lesion secretion
Timepoint
First, second and third prescriptions
Method of measurement
Objective
Secondary outcomes
empty
Intervention groups
1
Description
Irrigation of burn lesion, debridement, if necessary and dressing using vaseline guaze as well as oral acetaminophen.
Category
Treatment - Other
2
Description
Burn lesion irrigation, debridement, if necessary and dressing using the topical burn ointment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. M. R. Saberi
Street address
Pharmacy school, Vakilabad Boulevard
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Morvarid co.
Full name of responsible person
Dr. Ahmad Sadeghi
Street address
G98, Shokouhieh Industrial Zone
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Morvarid 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
Pharmacy School, Mashhad University of Medical Science
Full name of responsible person
Dr. Mohammad Reza Saberi
Position
Associate Professor
Other areas of specialty/work
Street address
Vakil Abad Blvd.
City
Mashhad
Postal code
Phone
+98 51 1802 3041
Fax
Email
saberimr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmacy School, Mashhad University of Medical Science
Full name of responsible person
Dr. Mohammad Reza Saberi
Position
Associate Professor
Other areas of specialty/work
Street address
Vakil Abad blvd.
City
Mashhad
Postal code
Phone
+98 51 1802 3041
Fax
Email
SaberiMR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pharmacy School, Mashhad University of Medical Science
Full name of responsible person
Dr. Mohammad Reza Saberi
Position
Associate Professor
Other areas of specialty/work
Street address
Vakil Abad blvd.
City
Mashhad
Postal code
Phone
+98 51 1802 3041
Fax
Email
SaberiMR@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)