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The effect of Centella asiatica ointment on third degree burns in patients to the burn center of burns in the province of Rasht in 2018

Protocol summary

Study aim
The effect of centella asiatica ointment on third degree burning wound
Design
Two parallel group double blind randomized controlled trial
Settings and conduct
This study will be performed due to importance of burning and will be held in Velayat hospital and double blind clinical trial in which physician and patient will be blind to type of drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: age more than 18 years, Third degree burning wounds, involvement of lesser than 25% of total body surface area, surface of lesser than 1 cm2 in burning wound area, burning in limbs and trunk, time from burning lesser than 48 hours, lack of any other lesion except burning, general and mental health Exclusion criteria are: no consent to participate, lack of ability to do follow up, existence of any cerebrovascular, cardiovascular, endocrine, liver and kidney disorders, history of abuse of alcohol or substances, concurrent use of antibiotic (topical and oral), steroid or immuno-suppressive drugs, pregnancy
Intervention groups
group receiving centella asiatica ointment and group receiving silver sulfadiazine
Main outcome variables
time to re-epithelialization and time to complete healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131006014915N2
Registration date: 2018-09-13, 1397/06/22
Registration timing: registered_while_recruiting

Last update: 2018-09-13, 1397/06/22
Update count: 0
Registration date
2018-09-13, 1397/06/22
Registrant information
Name
Amin Saeidinia
Name of organization / entity
Medicinal plants research center of student Basij, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1669 0099
Email address
a.saeidynia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Centella asiatica ointment on third degree burns in patients to the burn center of burns in the province of Rasht in 2018
Public title
The effect of herbal ointment containing centella asiatica on third degree burning wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Third degree burning wounds involvement of lesser than 25% of total body surface area surface of lesser than 1 cm2 in burning wound area burning in limbs and trunk time from burning lesser than 48 hours lack of any other lesion except burning general and mental health more than 18 years old
Exclusion criteria:
no consent to participate lack of ability to do follow up existence of any cerebrovascular, cardiovascular, endocrine, liver and kidney disorders history of abuse of alcohol or substances concurrent use of antibiotic (topical and oral) steroid or immuno-suppressive drugs pregnancy
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
burning wound in every limb and in trunk or against limb
Randomization (investigator's opinion)
Randomized
Randomization description
four blocked, block randomization by using a, b, c, d block in randomization, in a way that groups will be allocated in considered intervention group by determined respect and equally.
Blinding (investigator's opinion)
Double blinded
Blinding description
blinding will be done by pocket and physician and patient will be blinded to type of drugs
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
First floor, Research and Technology assistant, Shahid Siadati street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2018-09-04, 1397/06/13
Ethics committee reference number
IR.GUMS.REC.1397.201

Health conditions studied

1

Description of health condition studied
Third degree burn
ICD-10 code
T21.3
ICD-10 code description
Burn of third degree of trunk

2

Description of health condition studied
Third degree burn
ICD-10 code
T22.3
ICD-10 code description
Burn of third degree of shoulder and upper limb, except wrist and hand

Primary outcomes

1

Description
Re-epithelialization
Timepoint
0, 3 and 14 days and then the day epithelialization completed
Method of measurement
examination

2

Description
complete healing of derm
Timepoint
0, 3 and 14 days and then the day epithelialization completed
Method of measurement
examination

Secondary outcomes

1

Description
visual analogue scale
Timepoint
0, 3 and 14 days after burn
Method of measurement
pain ruler

Intervention groups

1

Description
Intervention group: using centella asiatica ointment
Category
Treatment - Drugs

2

Description
Control group: using silver sulfadiazine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat burning center
Full name of responsible person
Mohammad Reza Mobayen
Street address
Velayat Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8714
Email
vellayat.info@gmail.com
Web page address
http://www.gums.ac.ir/velayat

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
First floor, Research and Technology assistant, Shahid Siadati street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
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

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Amin Saeidinia
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Medical faculty, Guilan University, 10th kilometer Tehran road, Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
3363
Phone
+98 13 1669 0099
Fax
Email
a.saeidynia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Mobayen
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Velayat Hospital, Namjoo street
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8714
Email
maziar.mobayen@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mahdi Nabaei
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Velayat Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8714
Email
mahditaleghan@chmail.ir

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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data can be shared after non-labeled of name of participants
When the data will become available and for how long
after publishing the article till unlimited time
To whom data/document is available
scientific and academic institutes
Under which criteria data/document could be used
after sending request and after evaluation it will be available
From where data/document is obtainable
with corresponding scientific author
What processes are involved for a request to access data/document
sending email of request to corresponding author, evaluation and after confirmation of it, sending necessary data
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