The design of this study is a single blind clinical trial. The aim of the study is to evaluate the effect of the herbal roots of the Arnebia euchroma ointment(AE) dressing and silver sulfadiazine(SSD) dressing on wound healing in burn patients. After getting informed consent, 30 patients will be participating in the emergency department of the Sari Zare burn hospital. The side of the patient's burns are randomly assigned to the AE ointment or SSD cream treatment. Inclusion criteria: Men and women aged 16 to 65 years; bilateral and similar depth second degree burn wound in two different sides of the body.Exclusion criteria: pregnant women; Patients who have a serious disease of the liver, heart, kidney; diabetic patients; skin sensitivity and no willingness to participate in this study. After primary care of the wound, One side of the body will be treated with Arnebia euchroma ointment and the opposite site will be treated with routine method (silver sulfadiazine cream). The size of the wound will measure by the photography and ruler every two days. Wound area and percentage of wound contraction, healing time will be evaluated. Clinical assessment of recovery such as itching, bleeding, redness, pain, burning and infection will be blind evaluated during dressing by expert physician and nurse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412154492N2
Registration date:2015-02-23, 1393/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Ebrahim Nasiri formi
Name of organization / entity
Mazansdaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00981513261245- 00981513261246
Email address
enasiri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Mazandaran University of Medical Sciences
Expected recruitment start date
2014-12-16, 1393/09/25
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of herbal root of the Arnebia euchroma ointment and silver sulfadiazine on second degree burn wound
Public title
The effect of herbal root of the Arnebia euchroma ointment on second degree burn wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: bilateral second degree burn wound; aged 16 to 65 years.
Exclusion criteria: pregnant women; existing of systemic disease such as diabetic patients; Cardiovascular disease; hypertension; Renal failure; Skin sensitivity; no willingness to participate.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Mazandaran University of Medical Sciences
Street address
Deputy of research of Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
4847144718
Approval date
2012-08-20, 1391/05/30
Ethics committee reference number
2504/4/ - 09/09/93
Health conditions studied
1
Description of health condition studied
Burn and corrosion of head and neck
ICD-10 code
T20.2
ICD-10 code description
Burn of second degree of head and neck
2
Description of health condition studied
Burn and corrosion of trunk
ICD-10 code
T21.2
ICD-10 code description
Burn of second degree of trunk
3
Description of health condition studied
Burn and corrosion of shoulder and upper limb
ICD-10 code
T22.2
ICD-10 code description
Burn of second degree of shoulder and upper limb
4
Description of health condition studied
Burn and corrosion of wrist and hand
ICD-10 code
T23.2
ICD-10 code description
Burn of second degree of wrist and hand
5
Description of health condition studied
Burn and corrosion of hip and lower limb
ICD-10 code
T24.2
ICD-10 code description
Burn of second degree of hip and lower limb
6
Description of health condition studied
Burn and corrosion of ankle and foot
ICD-10 code
T25.2
ICD-10 code description
Burn of second degree of ankle and foot
Primary outcomes
1
Description
Wound size
Timepoint
First day of burn injury; The third day; The fifth day; The seventh day; The tenth day; The twelfth day; The fifteenth day; The twentieth day; Twenty- fifth day; The thirtieth day
Method of measurement
By photograph and ruler
Secondary outcomes
1
Description
Infection
Timepoint
daily
Method of measurement
observation
2
Description
Pain
Timepoint
daily
Method of measurement
VAS scale
3
Description
Itching
Timepoint
daily
Method of measurement
Visual analog scale
4
Description
secretion
Timepoint
during daily dressing
Method of measurement
Observation
5
Description
Inflammation
Timepoint
daily
Method of measurement
Observation
6
Description
Redness
Timepoint
daily
Method of measurement
observation
7
Description
Burning
Timepoint
daily during dressing
Method of measurement
Visual analoge Scale
8
Description
percentage wound contraction
Timepoint
each two days
Method of measurement
photography and ruler
Intervention groups
1
Description
A burned patient will be treated daily with tiny layer of the Arnebia euchroma ointment 10% on one part of the wound area. This process will be continued to complete of wound healing.
Category
Treatment - Drugs
2
Description
A burned patient will be treated daily with tiny layer of Silver sulfadiazine 1% on the second part of the wound are. This process will be continued to complete of wound healing.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn hospital of Zare, 5 th kilometer, Neka- Sari road.
Full name of responsible person
Ebrahim Nasiri
Street address
Zare psychiatry and burn center, 5 th kilometer, Neka- Sari road, Mazandaran University of Medical Sciences
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ravanbkhsh Esmaeili
Street address
Moallem Square, Deputy of research of Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Sayed Jalal Hosseinimehr
Position
Ph.D professor
Other areas of specialty/work
Street address
18 th kilometer of the Khazarabad, Mazandaran University of Medical Sciences
City
Sari
Postal code
48175-861
Phone
+98 11 3354 4308
Fax
Email
sjhosseinim@yahoo.com or sjhosseinim@mazums.ac.ir
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Sayed Jalal Hosseinimehr
Position
Professor of radiopharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy+ Traditional and Complementary research center, Mazandaran University of medical sciences
City
Sari
Postal code
48175-861
Phone
+98 11 3354 3691
Fax
+98 911 321 0663
Email
sjhosseinim@mazums.ac.ir + sjhosseinim@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Scienses
Full name of responsible person
Ebrahim Nasiri
Position
Faculty memberof Mazandaran University of Medical Scienses and Ph.D cadidate of Traditonal and compl
Other areas of specialty/work
Street address
Traditonal and complementary research center of Mazandaran University of Medical Scienses
City
Sari
Postal code
4847116548
Phone
+98 11 3354 3239
Fax
Email
enasiri@mazums.ac.ir
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)