Assessing therapeutic effects of a topical ointment containing the extract of Arnebia euchroma and amniotic membrane in patients with burn; a randomized controlled trial
Determining the therapeutic effect of ointment containing Arnebia euchroma extract and amniotic membrane in patients with burn wounds
Design
patients with 1st or 2nd degree burn wounds are divided into two groups. Patients in both groups receive standard treatment for burn wounds. One group apply Abu Khalsa ointment and the other group apply silver sulfadiazine every 24 hours for 14 days. Wound healing is investigated by determining its extent and the time required for wound healing in the Abu Khalsa ointment group is compared with the silver sulfadiazine group. Statistical t and chi square tests will be used to compare the effects of herbal medicine and silver sulfadiazine on the important parameters of days of recovery after treatment, wound size, edema, hematoma, itching, pain, and infection.
Settings and conduct
Patients rub the medicine on the wounds every 24 hours for 14 days.
The study is conducted in Razi Hospital.
On the can of medicines, a label with the title 1 or 2 is placed, and the patient and other people are unaware of the meaning of the numbers on the label.
Participants/Inclusion and exclusion criteria
Entry criteria
- Age 18 to 60 years
- Second degree burns
- The extent of wound between 1 and 10%
- Less than 6 hours should pass from the occurrence of the burn to the time the patient goes to the treatment center
- The location of the wound is on the limbs and trunk
Non-entry criteria
- Suffering from underlying diseases
- Taking drugs that weaken the immune system
- The patient's unwillingness to continue participating in the research
Intervention groups
intervention group apply Arnebia euchroma ointment and the control group apply silver sulfadiazine every 24 hours for 14 days on the wounds.
Main outcome variables
the time required to heal the wound; wound size; human; hematoma; itching; pain; infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181005041243N4
Registration date:2024-07-08, 1403/04/18
Registration timing:prospective
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Nika Kianfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 7201
Email address
N-kianfar@alumnus.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-01, 1403/06/11
Expected recruitment end date
2025-09-02, 1404/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing therapeutic effects of a topical ointment containing the extract of Arnebia euchroma and amniotic membrane in patients with burn; a randomized controlled trial
Public title
Therapeutic effect of ointment containing extract of Arbenia Euchromia plant and amniotic membrane in burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-60
Burns due to contact with hot liquids or heat sources, patients with second degree burns according to the criteria determined according to the reference sources as follows: 1. The surface of the burn is red or pink in color. 2- It has a moist surface with liquid oozing or accompanied by blisters. 3- Having extreme sensitivity when touching
The extent of the burn wound is between 1 and 10%, which is determined based on the criteria of Lund and Browder
Less than 6 hours should pass from the occurrence of the burn to the time the patient goes to the treatment center
The patient's wound was free of infection and trauma
The wound of the patient should be only on the limbs and trunk and not in the head, face and genital area.
Exclusion criteria:
Suffering from diseases such as anemia, diabetes, malignancies and immune system defects due to the impact on the wound healing process.
Taking drugs that weaken the immune system and are effective on wound healing, such as steroid drugs - substance abuse
The patient's unwillingness to continue participating in the research or not returning to the treatment center
Damage to the burn wound during the intervention, chemotherapy or radiation therapy during the research and showing signs of sensitivity to 1% silver sulfadiazine or the study drug during the intervention
pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of individuals to groups is done in the form of random allocation in blocks of four. In this way, first the volume of each block is specified (block of four), then the list of blocks is specified with the help of www.randomizer.org and numbers are assigned to them (numbers 1 to 15 for 60 people) and each of the numbers with the list of treatment specific to you is placed in an envelope. Then, the people included in the research randomly select envelopes containing numbers between 1 and 15, and the allocation of people to two groups 1 and 2 is determined based on the list of four blocks of each number.
Blinding (investigator's opinion)
Single blinded
Blinding description
A label is placed on the can containing the drug and 1% silver sulfadiazine. The number 1 or 2 is written on the sticker of the can containing medicine (extract) and the number 1 or 2 is written on the label of the can containing 1% silver sulfadiazine. Other specifications included on the said labels are completely the same. The patient and other people are unaware of the nature and meaning of the numbers 1 and 2 on the label. The place of blinding is in the research institute.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.135
Health conditions studied
1
Description of health condition studied
Burn wound
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining the extent of the wound and the time required to heal the wound
Timepoint
At the beginning of the study (before the start of the intervention) and 14 days after starting to use ointments
Method of measurement
The size of the wound is determined by a ruler and the time required to heal the wound is determined by a doctor's visit.
Secondary outcomes
1
Description
edema; hematoma; itching; pain; infection
Timepoint
At the beginning of the study (before the start of the intervention) and 14 days after starting to use ointments
Method of measurement
doctor's opinion
Intervention groups
1
Description
Intervention group: Ointment name: Arnebia euchroma, chemical composition and its concentration: extracts are prepared by soaking plant materials in (67%-EtOH) under ultrasound at room temperature. The extracts will be filtered through Whatman No. 1 filter paper, and then the filtrates were successively combined and concentrated under vacuum by a rotary evaporator. Then, in a special mill, the dry extract will be mixed with the oily base composition and it will be kept for 73 hours in a special tank in the dark at a temperature of 37 degrees Celsius. The final product is sterilized by gamma radiation (23 kg). Dosage: In both groups, after washing the burn wound with 0.9% sterile saline solution, the wound is placed in the vicinity of the open air for 5 minutes until its surface is completely dry, then using a sterile water hose to complete the measurements. The surface of the burn wound should be covered with a thickness of 3 mm, ointment number 1 or 2 is applied to the wound, and a layer of sterile gauze is placed on the wound. Wound dressings are changed daily for up to 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Maryam Nasimi
Street address
Razi Hospital, Vahdate eslami St.
City
Tehran
Province
Tehran
Postal code
11996 6391
Phone
+98 21 5563 0553
Email
nsm.maryam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Reza Ghafarzadegan
Street address
Medicinal Plants Research Institute, Jihad Academic Research Complex, Behesht Sakineh St., Karaj-Qazvin freeway
City
Tehran
Province
Tehran
Postal code
131451446
Phone
+98 26 3476 4010
Email
sec.imp@acecr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Nasimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
Razi Hospital, Vahdate eslami St.
City
Tehran
Province
Tehran
Postal code
11996 63911
Phone
+98 21 5563 0553
Email
nsm.maryam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Nasimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
Razi Hospital, Vahdate eslami St.
City
Tehran
Province
Tehran
Postal code
11996 63911
Phone
+98 21 5563 0553
Email
nsm.maryam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Nasimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Practitioner
Street address
Razi Hospital, Vahdate eslami St.
City
Tehran
Province
Tehran
Postal code
11996 63911
Phone
+98 21 5563 0553
Email
nsm.maryam@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
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
Part of the data, such as the information related to the main outcome, can be shared. All information will be published in the form of a work report and finally a scientific article. If you need all the data, it is possible for the person in charge of the plan to provide the information without patients being identifiable.
When the data will become available and for how long
The access period starts immediately after the results are printed
To whom data/document is available
Only researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will only be given to researchers who are researching the same topic.
From where data/document is obtainable
Responsible for the project: Dr. Maryam Nasimi
Address: Razi Hospital, Vahdat Eslami St.
Number: 09128435986
Email: nsm.maryam@gmail.com
What processes are involved for a request to access data/document
After sending a reasonable request to the person in charge of the project by email, if the conditions are met, the information will be shared with them.