Comparative study of Zoush herbal ointment and silver sulfadiazine ointment in the healing and treatment of grade 2 burn wounds
Design
To perform the phase of a clinical trial: A non-randomized, non placebo and not controlled, study of 30 healthy volunteers with major inclusion criteria.
Settings and conduct
To apply herbal ointment, the upper extremities of volunteers in the anterior region of the right or left forearm from the elbow to the wrist joint will be selected as impregnated with a 5 mm thick herbal ointment. The impregnation site is first rinsed with 0.9% normal saline and the dressing will be applied after the use of the ointment. At all stages of treatment, before the daily dressing of the area used, sensitivity and potential infection and any adverse reactions will be assessed. Blood samples were taken from 30 volunteers before and at the end of the intervention, and serum and urea and creatinine enzymes (ALP-AST-ALT) were measured and compared before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy male or female volunteers aged 20-50 years old, without underlying disease such as diabetes; immune deficiency and skin problems; not using cigarettes and alcohol; willing to participate in research and able also to answer questions. Exclusion criteria in the first phase: any skin allergies to ointment and causing infection and fever; pain in the area of Zoush ointment; unwillingness to cooperate.
Intervention groups
A group of 30 healthy volunteers.
Main outcome variables
If the herbal ointment did not show any side effects, such as skin allergy and infection, as well as changes in liver enzymes and renal excretion samples before and after intervention in the blood serum of volunteers, then the next phase of clinical study would be performed on burn patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200301046653N1
Registration date:2020-04-10, 1399/01/22
Registration timing:prospective
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
mehdi nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3680 4015
Email address
nazarimahdi90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cilinical Study the Effect of Zoush in Comperhansive Sulfadiazine 1 Ointment on Second-degree Burned Wound Healing
Public title
Effect of Zoush herbal ointment in burn treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy female or male volunteers aged 20 to 50 years old
Be willing to participate in research and be able to answer questions
Has read and signed the informed consent form
Exclusion criteria:
Have underlying illnesses such as diabetes and immune deficiencies such as cancer, AIDS
Have severe skin allergies and skin problems
People who use cigarettes and alcohol
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Unit 3, No. 50, Next to East Laleh First Health Park, Boulevard Imam Khomeini, Ferdis, Karaj
City
karaj
Province
Alborz
Postal code
3143843711
Approval date
2020-03-04, 1398/12/14
Ethics committee reference number
IR.ABZUMS.REC.1398,252
Health conditions studied
1
Description of health condition studied
Second-degree Burned Wound
ICD-10 code
T23.2
ICD-10 code description
Burn of second degree of wrist and hand
Primary outcomes
1
Description
The size of the wound includes the depth and edge of the wound and the extent of the wound
Timepoint
Study days 7, 14 and 21
Method of measurement
BATES JENSIN Wound Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in order to prepare the ointment of safflower herbs, thyme, Shiraz, oregano is purchased from the Barij essential oils and alcoholic extract. Finally, the extracts are powdered from the same company. The constituents of the extracts were measured using gas chromatography. The extracts are dissolved in a ratio of 1/3 in dimethyl sulfoxide. Honey is dissolved in distilled water in a ratio of 1/3. Polyurethane is dissolved in 6 m urea at a ratio of 1/3 and then subjected to indirect heat to evaporate urea. Extracts of Khuzestani, Thyme, and Oregano soluble, DMSO water-soluble honey and polyurethane soluble in urea are mixed in a separate falcon in a ratio of one to one and used as the primary stack of zush ointment compounds in other stages. Will take. Zucchini ointment will be used daily for 21 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Mehdi Nazari
Street address
Unit 3,No. 50, Next to East Laleh First Health Park ,Boulevard Imam Khomeini, Ferdis, karaj
City
karaj
Province
Alborz
Postal code
3143843711
Phone
+98 26 3680 4015
Email
nazarimahdi90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nouri Sepehr
Street address
Deputy of Research and Technology., Saffarian Alley., 45 meters from Golshahr., Karaj Town.
City
karaj
Province
Alborz
Postal code
3143843711
Phone
+98 26 3464 3774
Email
dr.noorisepehr@abzums.ac.ir
Web page address
https://abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mehdi Nazari
Position
Master s dedree not science Committee
Latest degree
Master
Other areas of specialty/work
histology
Street address
Unit 3, No. 50, Next to East Laleh First Health Park, Boulevard Imam Khomeini, Ferdis
City
Karaj
Province
Alborz
Postal code
3143843711
Phone
+98 26 3680 4015
Email
nazarimahdi90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Leila Haj Maghsoudi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Burn Clinic, Madani Hospital, Madani Square, Jahanshahr, Karaj Town
City
Karaj
Province
Alborz
Postal code
11111111111111
Phone
+98 26 3680 4015
Email
L.hajimaghsoudi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mehdi Nazari
Position
Master s dedree not science Committee
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Unit 3, No. 50, Next to East Laleh First Health Park, Boulevard Imam Khomeini, Ferdis
City
karaj
Province
Alborz
Postal code
3143843711
Phone
+98 26 3680 4015
Email
nazarimahdi90@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Yes - There is 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
Information about the results and data of the study subjects can be shared.
When the data will become available and for how long
The access period begins 6 months after the results are published.
To whom data/document is available
Data will be available only to researchers working in universities.
Under which criteria data/document could be used
Data recipients can only read and reference the article. And any misuse of the results is subject to prosecution as the drug formulation is patented.
From where data/document is obtainable
Applicants may request to receive study data by emailing the principal investigator nazarimahdi90@gmail.com and phone number 09126474345
What processes are involved for a request to access data/document
After receiving the email from the Principal Investigator, the data will eventually be sent to the applicant's workplace at the relevant medical university within 30 working days.
Comments
Given that this research project has been the result of an effort in the animal phase since 1993, it is only possible to use the data from the clinical trial of this study in compliance with existing rules and regulations.