Evaluation of the effectiveness of bed wound gel prepared from medicinal plants
Design
The clinical trial in this study has two groups of patients diagnosed with bedsores and a control group diagnosed with bedsores and receiving placebo, with parallel groups, double-blind in phase 3 with the number of 60 patients. The rand function of Excel software was used for randomization. In this way, a numerical code is randomly assigned to each person.
Settings and conduct
Recent studies show that the extracts of some medicinal plants are effective in the treatment of bedsores and diabetic foot ulcers, and if they are prepared in gel form, they will be patient-friendly. The location of this study is Valiasr International Hospital in Tabriz. In this study, 60 patients diagnosed with bedsores and diabetic foot ulcers were selected in two control and treatment groups. In this study, all people involved in the study are blind except for the main presenter.
Participants/Inclusion and exclusion criteria
The condition for entering the study is to have bedsores.
Anyone who does not have bed sore disease will not be included in the study.
Intervention groups
In intervention group A, 50 grams of gel is applied three times a day for one month on the wound site.
In the control group, 50 grams of placebo gel is applied to the wound site three times a day for one month.
Main outcome variables
The outcome is a dependent variable whose relationship is measured with an independent variable called the intervention. Complete or incomplete recovery and even worsening or unchanged diabetic foot ulcers are among the main outcomes that can be related to the measurement of the size of the ulcers (intervening effect).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240318061329N1
Registration date:2024-04-26, 1403/02/07
Registration timing:prospective
Last update:2024-04-26, 1403/02/07
Update count:0
Registration date
2024-04-26, 1403/02/07
Registrant information
Name
Aliasghar Hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 2250
Email address
hamidia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the therapeutic effects of wound bed gel prepared from medicinal plants
Public title
Investigation the therapeutic effects of wound bed gel prepared from medicinal plants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with bed sores
Patient with diabetic foot
Exclusion criteria:
There is no precedent
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
In this parallel design, patients are divided into two groups receiving the main drug and the group receiving placebo.
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient is assigned a random numerical code by Excel software
Blinding (investigator's opinion)
Double blinded
Blinding description
All subjects were blind except the principal investigator
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
CNG Station, Molla Sadra Avenu, Niyayesh Square, TABRIZ 5165995611, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5165995611
Approval date
2024-04-03, 1403/01/15
Ethics committee reference number
IR.TBZMED.REC 1402.967
Health conditions studied
1
Description of health condition studied
Bed sores and Diabetic foot ulcer
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
The outcome variable in this study is scoring the wound size during the study.
Timepoint
In this study, on the day of the start of the study, 10 and 21 days after the start of the study, the gel is used three times a day, and three 50-gram gels are considered for each participant.
Method of measurement
In this study, the effectiveness of the gel made for the treatment of bedsores and diabetic foot ulcers is evaluated through a questionnaire. In the questionnaire, wound size, wound depth, wound edges, type and amount of necrotic tissue, type and amount of exudate or purulent secretions, edema around the wound and skin color around the wound are measured.
Secondary outcomes
1
Description
One of the goals of treatment in the thirty-day period will be to prevent wound infection as a secondary consequence.
Timepoint
On the first day, the tenth day, and the twenty-first day, the wound infection treatment is checked. In the formulation of this gel, a plant with antibacterial properties has been used.
Method of measurement
Pain around the wound, smelly wound, thick yellow or green infection and swelling around it are signs and symptoms of bed sore infection. Fever, confusion, increased heart rate and physical weakness are also signs of the spread of infection in the body. To treat a local (non-systemic) infection, a microbial culture is performed from the wound, and after preparing an antibiogram, an effective antibiotic is prescribed according to the doctor's opinion. . In systemic infection, WBC, CPR, ESR tests are requested and necessary treatment is started.
Intervention groups
1
Description
Intervention group: The group that receives the drug-containing gel three times a day. Bedsores develop on areas of the skin that are under pressure from lying in bed, sitting in a wheelchair, or wearing a cast for a long time. The treatment plan includes the following steps: Reducing the pressure on the wound, cleaning and disinfecting the wound bed, covering the bed wound, removing dead tissue from the skin, applying gel containing medicine to the wound and using appropriate antibiotics to prevent infection. Diabetic foot ulcers often occur in the big toe, and the treatment protocol includes the following steps: preventing the wound from becoming infected by using appropriate antibiotics, removing any pressure or physical damage from the wound site, removing dead cells and tissues from the wound, and Disinfection of the wound. The material used in this gel is a 10% extract consisting of several medicinal plants such as Anacyclus pyrethrum, valerian valeriana officinalis, saffron, honey, etc., for proper formulation, carbomer as a gelling agent, triethanolamine to adjust pH, and isothiazoline 0.1% to It was used as an antibacterial agent. The manufacturer of cosmetic laboratory gel was Dr. Khosh Raj in Tabriz.
Category
Treatment - Drugs
2
Description
Control group: The group that receives placebo gel three times a day. The treatment protocol of the intervention group and the control group is the same, with the difference that the intervention group receives medicine and the control group receives a placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Valiasr Hospital
Full name of responsible person
Hadi Hamishehkar
Street address
Opposite the entrance of Zafaranieh, Valiasr Hospital, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1855951666
Phone
+98 41 3327 3000
Email
hamishehkar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Central Organization of University, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Aliasghar Hamidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Square, Molla Sadra St., next to the CNG station, Food and Drug Deputy, Management of Food and Drug Control Laboratories
City
Tabriz
Province
East Azarbaijan
Postal code
5165995611
Phone
+98 41 3177 4433
Email
hamidia@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliasghar Hamidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Square, Molla Sadra St., next to the CNG station, Food and Drug Deputy, Management of Food and Drug Control Laboratories
City
Tabriz
Province
East Azarbaijan
Postal code
5165995611
Phone
+98 41 3177 4433
Email
hamidia@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aliasghar Hamidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Square, Molla Sadra St., next to the CNG station, Food and Drug Deputy, Management of Food and Drug Control Laboratories
City
Tabriz
Province
East Azarbaijan
Postal code
5165995611
Phone
0098041031774433
Email
hamidia@tbzmed.ac.ir
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
Yes - There is 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
Title and more details about the data/document
There is no further information.
When the data will become available and for how long
There is no further information.
To whom data/document is available
There is no further information.
Under which criteria data/document could be used
There is no further information.
From where data/document is obtainable
There is no further information.
What processes are involved for a request to access data/document