Protocol summary
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Study aim
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Investigating the effectiveness of greeد natural dressing containing milk and propolis with honey on bedsores, burn wounds and diabetic foot wounds
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Design
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Clinical trial with control group, double blind, randomized, phase 1 on 160 patients.
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Settings and conduct
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The wound dressing will be prepared at Sepahan Behdoh Company in Isfahan. Patients referred to Shahid Beheshti Hospital are selected by a specialist doctor. The dressing will be placed on the damaged wound and its healing process will be monitored by the attending physician for two weeks and every day after dressing.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients with ulcers caused by bedsores, patients with diabetic foot ulcers, and patients with ulcers caused by burns are eligible to be included in the study.
Exclusion criteria:
Pregnant women and lactating women , patients who have deep wounds with abscess, osteomyelitis, local or extensive non-debridement gangrene, as well as patients with venous ulcers are not eligible for the study.
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Intervention groups
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The intervention group is the group that will receive the natural wound and the control group is the group that will receive the usual dressing as a wound dressing.
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Main outcome variables
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Wound quality and healing of infection
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200516047462N6
Registration date:
2024-03-16, 1402/12/26
Registration timing:
prospective
Last update:
2024-09-09, 1403/06/19
Update count:
1
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Registration date
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2024-03-16, 1402/12/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-03-25, 1403/01/06
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Expected recruitment end date
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2025-02-08, 1403/11/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of gree natural dressing containing milk and propolis with honey on diabetic foot ulcers, bedsores and burns:A clinical trial
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Public title
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The effect of milk and propolis with honey on infectious wounds
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with ulcers caused by bedsores
Patients with diabetic foot ulcers
Patients with ulcers caused by burns
Exclusion criteria:
Pregnancy and breast feeding
Patients who have a deep wound with abscess, osteomyelitis, the presence of local or extensive non-debrideable gangrene
Patients with venous ulcers and evidence of malignancy in the wound area
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done in a simple way and the table of random numbers will be used as a tool. Even numbers are for the intervention group and odd numbers are for the control group. Then, according to the number of the studied sample, the corresponding numbers are extracted from the table of random numbers or using a computer, and each number is written on a card and placed in an envelope, and the envelopes are sealed, and on each envelope the number The patient is written. The first patient who is enrolled in the study and enters the study will be given the envelope related to patient number 1, patient number 2 will be given envelope number 2 and so on, and this will continue until the end of the study sample. In order to maintain randomization, the person who prepares the envelopes will be different from the person who registers the patients and provides the envelopes to the patients.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The researcher and the patients present in the studies are blinded . This means that both groups do not know which group the patients are in. And they do not know whether the patients are prescribed medicine or a placebo . During wound dressing, During wound dressing, all patients will be told that the same dressings will be used for them
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-02-12, 1402/11/23
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Ethics committee reference number
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IR.KAUMS.REC.1402.014
Health conditions studied
1
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Description of health condition studied
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زخم های عفونی
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ICD-10 code
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S01.0
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ICD-10 code description
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Open wound of scalp
Primary outcomes
1
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Description
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Complete healing of the lesion
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Timepoint
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On arrival or day zero, 2, 4, 7, 14 and 21 days after treatment
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Method of measurement
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Based on measuring the diameter of the induration of the lesion using a caliper
Intervention groups
1
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Description
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Intervention group: The wound dressing is produced in Sepahan Behdoh Company, Isfahan. Patients referred to Patients referred to medical centers under the Kashan University of Medical Sciences, Ahvaz and Shahrekord University are selected by a specialist doctor. Covered wounds containing propolis, milk and honey are used on leg wounds, bed sores.
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Category
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Treatment - Other
2
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Description
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Control group: The wound dressing is produced in Sepahan Behdoh Company, Isfahan. Patients referred to Shahid Beheshti Hospital in Kashan are selected by a specialist doctor. The wound dressings have the same packages as the intervention group
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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5
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information about participants such as age, gender, level of education and employment will be reported. The treatment protocol and the duration of treatment process will be reported. Therapeutic results of the product and possible side effects will be reported.
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When the data will become available and for how long
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The start of the access period will be 6 months after patent presentation or 12 months after article publication.
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To whom data/document is available
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The data will be available to researchers working in academic and scientific institutes.
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Under which criteria data/document could be used
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The data printed in the article is accessible.
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From where data/document is obtainable
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Moderator: Morteza Kosari Email address: kosarimorteza12@gmail.com
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What processes are involved for a request to access data/document
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This access will be based on the treatment protocol in hospitalized patients and treatment results, and includes effective ingredients and how to make the privacy cream of the project implementers. We will try to respond to researchers as soon as possible.
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Comments
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