Comparison of the effect of Arnebia euchrooma extract with nitrofurazone ointment on wound healing in second and burn patients
Design
In this study, 60 patients with second and third degree burns admitted to Ardabil University of Medical Sciences burn hospital were selected. Randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
Patients with second burns referred to Ardebil University of Medical Sciences burn hospital were selected through a single blinded study that participants in this study were not aware of the type of drug used.
Participants/Inclusion and exclusion criteria
Having a second or third degree burn wound; The shape of the burn wound is almost oval; general good; Exclusion criteria: A history of autoimmune diseases; HIV; A history of immunosuppressive drugs; A history of psychiatric disorders such as paranoid; A history of psychiatric hospitalization.
Intervention groups
Control group 1: Patients with second burns who will receive 0.2% nitrofurazone cream. Intervention group 1: Patients with second burns who will receive ointment containing proderm extract.
Main outcome variables
Evaluation and comparison of wound size using caliper and wound healing using wound photography on days 6, 12, 18 and 24 after treatment between the control and intervention groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200104045995N1
Registration date:2021-02-01, 1399/11/13
Registration timing:registered_while_recruiting
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Mohammad Vakili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3326 1600
Email address
mohammad.vakili@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effectiveness of proderm herbal ointment in comparison withnitrofurazone cream in second degree burn wounds
Public title
Effect of Ventilation on Burn Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a second degree burn wound
The shape of the burn wound is almost oval and regular
Burn with boiling water, fire and acid.
Exclusion criteria:
Having an underlying disease such as epilepsy
Having a history of autoimmune diseases; Getting HIV
History of taking immunosuppressive drugs
History of psychotic disorder such as paranoid
Hospitalization history in the psychiatric ward
Age
From 2 years old to 50 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
In this method, the number of people assigned to each group is usually equal. In this method, blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as controls. The main goal of this method is to balance the number of participants in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Daneshgah St. Daneshgah
City
ardebil
Province
Ardabil
Postal code
5618985991
Approval date
2020-08-03, 1399/05/13
Ethics committee reference number
IR.ARUMS.REC.1399.280
Health conditions studied
1
Description of health condition studied
Patients with second-degree burns
ICD-10 code
T29.2
ICD-10 code description
Burns of multiple regions, no more than second-degree burns mentioned
Primary outcomes
1
Description
Wound size
Timepoint
The first day and every other day until the wound is completely healed
Method of measurement
To mm using calipers
Secondary outcomes
1
Description
Wound healing rate
Timepoint
The first day and every other day until the wound is completely healed
Method of measurement
Wound imaging
Intervention groups
1
Description
The effect of a patented topical formulation containing standardized extracts of the medicinal plant Hawachobeh, castor oil and olive oil formulated in Danesh Banain Andisheh Sabalan Health Company and in healing wounds caused by second degree burns in comparison with nitrofurazone cream will be investigated. In such a way that two types of treatments include 1- use of nitrofurazone cream on second degree burns 2- use of proderm ointment on second degree burns that in both treatments of the burn site (hands, feet and face) cause and type of burn are common. The statistical population for each group of 30 people in the age range of 2 to 50 years of those referred to the burn ward of Fatemi Hospital who have burns on similar limbs (in terms of organ and burn site) and those who have burns on the back and abdomen They will be removed. Consumption of prodermal drug 2-3 mm in the burn site after washing with standard serum is applied topically on the wound once a day with sterile gas.
Category
Treatment - Drugs
2
Description
Control group: Patients with second-degree burns for whom nitrofurazone cream will be used daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
urn ward of Fatemi Hospital, Ardabil University of Medical Sciences
Full name of responsible person
mohamad vakili
Street address
amam
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۴۷۳۳۷۷۵
Phone
+98 45 3323 9033
Fax
+98 45 3323 2670
Email
fatemi@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
farhad pourfarzi
Street address
daneshgah
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
info@arums.ac.ir
Web page address
http://arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
شرکت اندیشه سلامت سبلان
Full name of responsible person
siyamak mohamadi
Street address
Dastqeib
City
Ardabil
Province
Ardabil
Postal code
5613786179
Phone
+98 45 3339 6430
Fax
+98 45 3339 6430
Email
savalanm452@gmail.com
Web page address
http://www.asproheal.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
شرکت اندیشه سلامت سبلان
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohamad vakili
Position
Specialty
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Emam
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۴۷۳۳۷۷۵
Phone
+98 45 3323 9033
Fax
+98 45 3323 2670
Email
mohammad.vakili@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohamad vakili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Emam
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۴۷۳۳۷۷۵
Phone
+98 45 3323 9033
Fax
+98 45 3323 2670
Email
mohammad.vakili@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Andishe Salamat Sabalan Co
Full name of responsible person
Hamed arastegi
Position
Expert
Latest degree
Master
Other areas of specialty/work
Medicinal Plants
Street address
Dastqeib
City
Ardabil
Province
Ardabil
Postal code
5613786179
Phone
+98 45 3339 6430
Fax
+98 45 3339 6430
Email
hamedaraz69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data includes the primary and secondary consequences that can be shared.
When the data will become available and for how long
6 months after printing the results.
To whom data/document is available
Our data will only be available to researchers working in academia and academia.
Under which criteria data/document could be used
Our data will be available to researchers working in academic and scientific institutions.
From where data/document is obtainable
Hamed Arastegi provides data to applicants via email hamedaraz69@gmail.com.
What processes are involved for a request to access data/document
Collecting patients and performing practical procedures for ten months, collecting data for one month, analyzing statistical data for one month, publishing information in the form of a six-month article.