Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Intervention groups
#1
Intervention 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. Covered wounds containing propolis, milk and honey are used on leg wounds, bed sores.
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.
Intervention group: The wound dressing is produced in Sepahan Behdoh Company, Isfahan. Patients referred to Shahid Beheshti Hospital inPatients 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.
گروه مداخله: زخم پوش ها در شرکت سپاهان بهبود اصفهان تهیه می گردد . بیماران مراجعه کننده به بیمارستان شهید بهشتی کاشان توسط پزشک متخصص انتخاب می گردند. زخم پوش طبیعی حاوی بره موم ، شیر به همراه عسل بر روی زخمی پای دیابتی ، زخم بستر و سوختگی استفاده خواهند شد
گروه مداخله: زخم پوش ها در شرکت سپاهان بهبود اصفهان تهیه می گردد . بیماران مراجعه کننده به مراکز درمانی زیر مجموعه دانشگاه علوم پزشکی کاشان ، اهواز و شهرکرد توسط پزشک متخصص انتخاب می گردند. زخم پوش طبیعی حاوی بره موم ، شیر به همراه عسل بر روی زخمی پای دیابتی ، زخم بستر و سوختگی استفاده خواهند شد
گروه مداخله: زخم پوش ها در شرکت سپاهان بهبود اصفهان تهیه می گردد . بیماران مراجعه کننده به بیمارستان شهید بهشتیمراکز درمانی زیر مجموعه دانشگاه علوم پزشکی کاشان ، اهواز و شهرکرد توسط پزشک متخصص انتخاب می گردند. زخم پوش طبیعی حاوی بره موم ، شیر به همراه عسل بر روی زخمی پای دیابتی ، زخم بستر و سوختگی استفاده خواهند شد
Recruitment centers
#1
Name of recruitment center - English: Shahid Beheshti Hospital of Kashan
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Morteza kosari
Full name of responsible person - Persian: مرتضی کوثری
Street address - English: Ghotb Ravandi Blvd, Shahid Beheshti Hospital of Kashan
Street address - Persian: بلوار قطب راوندی ، بیمارستان شهید بهشتی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 87159/81151
Phone: +98 31 5554 0026
Fax:
Email: beheshtihospital@kaums.ac.ir
Web page address:
Name of recruitment center - English: Kashan University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
Name of recruitment center - English: Shahid Beheshti HospitalKashan University of KashanMedical Sciences Name of recruitment center - Persian: بیمارستان شهید بهشتیدانشگاه علوم پزشکی کاشان Full name of responsible person - English: Morteza kosariKosari Full name of responsible person - Persian: مرتضی کوثری Street address - English: GhotbKashan University of Medical Sciences, Ghotbe Ravandi Blvd, Shahid Beheshti Hospital of Kashan Street address - Persian: بلوار قطب راوندی، بیمارستان شهید بهشتیدانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 87159/811518715988141 Phone: +98 31 5554 00262999 Fax: Email: beheshtihospitalresearch@kaums.ac.ir Web page address:
#2
Name of recruitment center - English: Ahvaz Jundishapur university of medical sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
Full name of responsible person - English: Jafar Jafarzadeh
Full name of responsible person - Persian: جعفر جعفر زاده
Street address - English: Golestan highway, Jundishapur University of Ahvaz
Street address - Persian: اهواز ،اتوبان گلستان،دانشگاه جندی شاپور اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 0000
Fax:
Email: eduaum@ajums.ac.ir
Web page address:
Name of recruitment center - English: Ahvaz Jundishapur university of medical sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز Full name of responsible person - English: Jafar Jafarzadeh Full name of responsible person - Persian: جعفر جعفر زاده Street address - English: Golestan highway, Jundishapur University of Ahvaz Street address - Persian: اهواز ،اتوبان گلستان،دانشگاه جندی شاپور اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3311 0000 Fax: Email: eduaum@ajums.ac.ir Web page address:
#3
Name of recruitment center - English: Shahrekord University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Maryam Keyhani dehnavi
Full name of responsible person - Persian: مریم کیهانی دهنوی
Street address - English: Kashani Blvd , Shahrekord University of Medical Sciences
Street address - Persian: شهرکرد، بلوار کاشانی ، دانشگاه علوم پزشکی
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: ۸۸۱۵۷۱۳۴۷۱
Phone: +98 38 3333 3815
Fax:
Email: kosarimorteza12@gmail.com
Web page address:
Name of recruitment center - English: Shahrekord University of Medical Sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی شهرکرد Full name of responsible person - English: Maryam Keyhani dehnavi Full name of responsible person - Persian: مریم کیهانی دهنوی Street address - English: Kashani Blvd , Shahrekord University of Medical Sciences Street address - Persian: شهرکرد، بلوار کاشانی ، دانشگاه علوم پزشکی City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: ۸۸۱۵۷۱۳۴۷۱ Phone: +98 38 3333 3815 Fax: Email: kosarimorteza12@gmail.com Web page address:
Protocol summary
Study aim
Investigating the effectiveness of greeد natural dressing containing milk and propolis with honey on bedsores, burn wounds and diabetic foot wounds
Design
Clinical trial with control group, double blind, randomized, phase 1 on 160 patients.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Wound quality and healing of infection
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
morteza kosari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 6622
Email address
yeganehbadi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-25, 1403/01/06
Expected recruitment end date
2025-02-08, 1403/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gree natural dressing containing milk and propolis with honey on diabetic foot ulcers, bedsores and burns:A clinical trial
Public title
The effect of milk and propolis with honey on infectious wounds
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2024-02-12, 1402/11/23
Ethics committee reference number
IR.KAUMS.REC.1402.014
Health conditions studied
1
Description of health condition studied
زخم های عفونی
ICD-10 code
S01.0
ICD-10 code description
Open wound of scalp
Primary outcomes
1
Description
Complete healing of the lesion
Timepoint
On arrival or day zero, 2, 4, 7, 14 and 21 days after treatment
Method of measurement
Based on measuring the diameter of the induration of the lesion using a caliper
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
2
Recruitment center
Name of recruitment center
Ahvaz Jundishapur university of medical sciences
Full name of responsible person
Jafar Jafarzadeh
Street address
Golestan highway, Jundishapur University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
eduaum@ajums.ac.ir
3
Recruitment center
Name of recruitment center
Shahrekord University of Medical Sciences
Full name of responsible person
Maryam Keyhani dehnavi
Street address
Kashani Blvd , Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 3815
Email
kosarimorteza12@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
5
Public or private sector
Private
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
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Medicinal
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimorteza12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimortza12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimortza12@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
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
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.
When the data will become available and for how long
The start of the access period will be 6 months after patent presentation or 12 months after article publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutes.
What processes are involved for a request to access data/document
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.