Protocol summary

Summary
Several dermatological effects of Centella asiatica including surgical and burning wound healing, increase of collagen and Fibronectin, blood flow in connective tissue and antimicrobial, anti-inflammatory and antioxidant properties, makes possible topical using it for treatment of burning and wound. This study is aimed to evaluate the effect of solution derived from Centella asiatica on partial thickness burning in patients referred to Velayat burning events center, Rasht. This is a double blind randomized clinical trial in which both physicians and patients are not aware of content of administrative drug in groups. Of patients with partial thickness burning and lower than 10% burning in the limbs, between 14-65 years old, with stable general condition, without history of concomitant major disease and history of drug consumption, 60 patients will be entered in the study. After confirming inclusion criteria and rule out of exclusion criteria, they were divided randomly into two remedial intervention and control groups. Control group will give routine treatment (Silver Sulfadiazine 1%) and intervention group will give solution derived from Centella asiatica. Patients will be evaluated as severity of pain and surface of burning in entering time, 2, 7 and 14 days after giving treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100614915N1
Registration date: 2014-10-11, 1393/07/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-10-11, 1393/07/19
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
Guilan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of topical ointment of Centella asiatica on partial thickness burning (A randomized clinical trial)
Public title
Effect of Centella asiatica on burning treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: every partial thickness burning with less than 10% involved body and being in limbs; time of burning less than 48 hours; No other injury except of burning lesion and have general health body; age between 14 to 60 years Exclusion criteria: Existence of every cerebro-vascular diseases; cardiovascular diseases; endocrine diseases; liver diseases; renal diseases; history of abuse in alcohol or drugs; using antibiotic (oral or parenteral) at the same time; steroid or other immunosuppressive drug; burning due to lightning arresting; electrical instruments ; local burning of hand
Age
From 14 years old to 60 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research assistance of Guilan University of Medical Sciences- Ethics Comitee
Street address
Research assistance of Guilan University of Medical Sciences, top of Iran radiator building, end of flying bridge, Imam Khomeini boulevard, Rasht, Iran
City
Rasht
Postal code
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
1920341317

Health conditions studied

1

Description of health condition studied
Partial thickness burning
ICD-10 code
T20-T25
ICD-10 code description
Burn of first degree of shoulder and upper limb, except wrist and hand

Primary outcomes

1

Description
Subjective symptoms
Timepoint
Day 2,7 and 14 after initiating treatment
Method of measurement
It will be scored by below symptoms: dryness: 1=yes, 0=no; itching: 1=yes, 0=no; irritation: 1=yes, 0=no

2

Description
Objective symptoms
Timepoint
Day 2,7 and 14 after initiating treatment
Method of measurement
It will be scored by below symptoms: Flexibility: 0=no, soft=1, yielding=2, stiff=3, sticky=4; Height: normal=0, 1-2mm=1, 3-4mm= 2, 5-6mm=3, >6mm=4; Vasculature: normal=0, pinky=1, red= 2, amethystine=3; Pigmentation: normal=0, mild=1, moderate=2, severe=3/ 0-4= lack of objective symptoms, 4-8= mild, 8-12= moderate, 12-14= severe

3

Description
Surface of burning
Timepoint
Day 2,7 and 14 after initiating treatment
Method of measurement
By evaluation of morphometric features with image analyzer software

4

Description
Severity of pain
Timepoint
Day 2,7 and 14 after initiating treatment
Method of measurement
By using Visual Analogue Score (VAS)

5

Description
Added at 2015-10-02: re-epithelialization
Timepoint
Added at 2015-10-02: from day o to complete of re-epithelialization
Method of measurement
Added at 2015-10-02: examination and observation with surgeon and sub-specialist of burning

6

Description
Added at 2015-10-02: Complete Healing
Timepoint
Added at 2015-10-02: from day o to complete of complete healing of scar
Method of measurement
Added at 2015-10-02: examination and observation with surgeon and sub-specialist of burning

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: using topical solution derived from Centella asiatica
Category
Treatment - Drugs

2

Description
Control group: treatment with Silver Sulfadiazine 1%
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat burning events center, Rasht
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Javad Golchai
Street address
Dermatology Department,Razi hospital, Sardare Jangal Street, Rasht, Guilan, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Amin Saeidinia
Position
Medical Student
Other areas of specialty/work
Street address
Medical faculty, Guilan University, 10th kilometer Tehran road, Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 13 1669 0099
Fax
Email
a.saeidynia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Javad Golchai; Dr. Ardalan Pasdaran
Position
Professor; Assistant Professor
Other areas of specialty/work
Street address
Razi hospital, Sardare Jangal Street, Rasht, Guilan, Iran/ Pharmacy faculty, Guilan University of Medical Sciences complex, Saravan-Fouman street, end of Lakan road, Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 13 1555 0028
Fax
Email
amin.saeidynia@gmail.com; ardalan.pasdar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Faeze Keihanian
Position
Medical Student
Other areas of specialty/work
Street address
Medical faculty, Guilan University, 10th kilometer Tehran road, Rasht, Guilan, Iran
City
Postal code
Phone
+1 316690099
Fax
Email
faezekeihanian@yahoo.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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