evaluation of the effect of Glycyrrhiza glabra root hydroalcoholic extract on the second‐degree burn wound healing
Design
The clinical trial has a control group, double-blind, randomized, phase 1 on 50 patients. Excel software rand function was used for randomization
Settings and conduct
Patients are selected from patients referred to Yazd Accident and Burn Hospital based on inclusion and exclusion criteria. Patients are treated with medication under the supervision of a physician and evaluated at the end of the study. The drugs are coded in the intervention and control groups and the physician and the patient do not know its content.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with second‐degree burn; Patients aged 16 to 65 years; Burns should occur no more than 24 hours before the start of treatment and involve less than 15% of the body surface.
exclusion criteria:
Patients with skin diseases; Allergy to silver sulfadiazine or licorice; Severe systemic diseases such as uncontrolled diabetes mellitus, epilepsy, immunodeficiency and pregnant women
Intervention groups
Licorice hydrogel receiving group; Base hydrogel receiving group
Clinical evaluation of the effect of Glycyrrhiza glabra root hydroalcoholic extract on the second degree burn wound healing.
Public title
Clinical evaluation of the effect of Glycyrrhiza glabra root hydroalcoholic extract on the second degree burn wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 2 burns.
Hip patients 16 to 65 years.
The burn must have occurred 24 hours before the start of treatment and involved less than one and a half percent of the body surface.
Exclusion criteria:
Patients with skin diseases.
Allergy to silver sulfadiazine or licorice.
Severe systemic diseases such as uncontrolled diabetes, epilepsy, immunodeficiency and pregnant women.
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with 2 degree burn who meet the inclusion criteria are placed in one of two groups A or B using random numbers obtained from the RAND function of Excel software. Licorice hydrogels or base hydrogels are each placed in a uniform container labeled A or B. So that only the first executor of the project is aware of the content of these containers and none of the doctors and patients know the content of each container.
Blinding (investigator's opinion)
Double blinded
Blinding description
Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.179
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Burn wound healing score
Timepoint
before intervention and 3, 10 weeks after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with hydrogel containing licorice will be treated topically for 15 days and standard treatment. Patients will be instructed to use only the products mentioned in the study and the necessary warnings will be given about using other household products. Treatment of the lesion condition is evaluated for the severity of redness, burning, edema, inflammation and pain (score 0 to 4). Patients will take the prescribed medication daily. After starting treatment, patients are evaluated every 5 days for the severity of redness, burning, edema, inflammation and pain.
Category
Treatment - Drugs
2
Description
Control group: Patients with hydrogel base will be treated topically for 15 days and standard treatment. Patients will be instructed to use only the products mentioned in the study and the necessary warnings will be given about using other household products. Treatment of the lesion condition is evaluated for the severity of redness, burning, edema, inflammation and pain (score 0 to 4). Patients will take the prescribed medication daily. After starting treatment, patients are evaluated every 5 days for the severity of redness, burning, edema, inflammation and pain.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Mehrab Hospital
Full name of responsible person
Ali Bemani
Street address
Moalem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۷۶۱۵۴۶۹
Phone
+98 35 3525 0936
Email
burn.hospital@chmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masood Mirzaei
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
School of Pharmacy
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
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Zabihi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916774520
Phone
+98 35 3820 3865
Fax
Email
mzabihi100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available