the effect of topical cream containing Chelidonium majus and and Hyoscyamus niger with propolis on healing of diabetic foot ulcer
Design
The clinical trial is designed as an intervention with a control group, double-blind, randomized, in phase 3 on 88 patients.
Settings and conduct
A double-blind study is performed on 88 patients with diabetic ulcers in Shahid Beheshti of Kashan and Al Zahra of Isfahan hospitals. The doctor and the patient do not know the type of treatment. The patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis during three weeks. The duration of each cream will be 6 days and the treatment will be done once a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic patients who take insulin, have diabetic foot ulcers and are in the age range of 18 to 85 years. Clinical judgment of the specialist physician based on receiving the product of patient's ability and its personal desire to fill out of personal consent form to enter the study.
Exclusion criteria:
Existence of any history of allergy to any herbal product.
Patients who need to surgery for their wounds
Intervention groups
Intervention group: Includes 44 patients with diabetic foot ulcers. These patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis during three weeks. The usage duration of each cream will be 6 days and the treatment will be done once a day.
Control group: Placebo will be used in addition to standard treatment in patients with diabetic foot ulcers for three weeks.
Main outcome variables
1- The extent of the wound
2- Angiogenesis
3- Tissue improvement
4- Duration of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047462N3
Registration date:2021-11-23, 1400/09/02
Registration timing:registered_while_recruiting
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
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
2021-11-21, 1400/08/30
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical cream of Chelidonium majus and Hyoscyamus niger with Propolis on diabetic foot ulcers
Public title
The effect of Chelidonium majus and Hyoscyamus niger with Propolis on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetes who take insulin and have diabetic foot ulcers and are in the age range of 18 to 85 years.
Clinical judgment of the specialist physician based on receiving the product
The patient's ability and its personal desire to fill out of personal consent form to enter the study
Exclusion criteria:
Existence of any history of allergy to any herbal product
Patients who need surgery for their wounds
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two groups by terminated block randomization method with blocks of 4 and 6, prescription drugs (intervention and placebo) are determined based on this method and a special number is assigned to them
Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on cream and only the epidemiologist informs as a plan executor.
Blinding (investigator's opinion)
Double blinded
Blinding description
A cream that has an active ingredient with a cream that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of color, and are completely indistinguishable. The important point is that the patient is told that the topical cream used for the patient may be medication or medication. Clinicians and patients will be blinded
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
Ghotb Ravandi Blvd, Shahid Beheshti Hospital, University of Medical Sciences, Kashan, Iran.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2021-06-26, 1400/04/05
Ethics committee reference number
َّIR.KAUMS.REC.1400.014
Health conditions studied
1
Description of health condition studied
Diabetic food ulcers
ICD-10 code
L97
ICD-10 code description
Ulcer of lower limb, not elsewhere classified
Primary outcomes
1
Description
Size and extent of wound
Timepoint
At the beginning of the study, 4 days after treatment and 7 days after treatment, 14 days after treatment, 21 days after treatment
Method of measurement
In millimeters
2
Description
The infiltration of inflammatory cells, neutrophils, monocytes, synthesis and maturation of collagen, fibroblasts and keratinocytes and induction of angiogenesis
Timepoint
21 days after treatment
Method of measurement
Tissue sample
3
Description
Nuclear hypertrophy of endothelial cells, vacuoles, diabetic foot ulcer granulation and tissue fibrosis
Timepoint
Twenty one days after treatment
Method of measurement
Histology
4
Description
The duration of treatment, the speed of recovery, the rate of symptoms reduction and the duration of disease recurrence
Timepoint
Twenty one days after treatment
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group is included 44 patients with diabetic foot ulcers. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 6 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Category
Treatment - Drugs
2
Description
The control group includes 44 patients with diabetic foot ulcers with Wegener 1, 2 and 3 and according to standard treatment receive medication along with placebo. Topical cream with no active ingredients is used for three weeks. The duration of use of each cream will be 6 days. The patient receives a maximum of 3 creams during the treatment period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Morteza kosari
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital of Kashan
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
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
10
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
Physiology
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
kosarimorteza12@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
Undecided - It is not yet known if there will be 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
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.