The Effects of Hydroalcoholic Extracts from Achillea millefolium, Teucrium polium, and Oak Fruit Inner Bark (Quercus brantii) Plants on the Healing of Skin Ulcers in Diabetic Patients - A Clinical Trial
The aim of this study is to determine the impact of hydroalcoholic extracts of Achillea millefolium, Teucrium polium, and oak fruit inner bark (Quercus brantii) plants on the healing of skin ulcers in diabetic patients.
Design
This is a randomized clinical trial with two parallel control and intervention groups, and a pilot study, involving a total of 25 patients. Randomization will be performed using the RAND function in Microsoft Excel.
Settings and conduct
The study will be conducted at the Diabetic Patients Clinic associated with YUMS. Eligible patients will be identified through physical examinations and review of their medical histories during the initial screening visit. Informed written consent will be obtained from each participant before any study-related procedures.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed consent to participate in the study.
ٍExclusion criteria:
Participation in another similar research.
Receipt of radiation or chemotherapy in recent times.
Use of local growth factors or biomedicals for ulcer treatment in the last 30 days.
Sensitivity to the used plants.
Smoking or drug use.
Intervention groups
Control Group: Diabetic patients with ulcers under standard treatment without receiving plant extracts.
Intervention Group: Diabetic patients with ulcers under standard treatment with the administration of plant extract.
Main outcome variables
Weekly clinical assessment of primary outcomes (complete ulcer healing) and secondary outcomes (reduction in ulcer size, tissue quality improvement, reduction in exudate, and history of side effects) will be evaluated using planimetry and photography at the initial visit and 3 weeks after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230523058265N1
Registration date:2023-11-18, 1402/08/27
Registration timing:registered_while_recruiting
Last update:2023-11-18, 1402/08/27
Update count:0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Hassan Bardania
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3344 4079
Email address
hasan.bardania@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Hydroalcoholic Extracts from Achillea millefolium, Teucrium polium, and Oak Fruit Inner Bark (Quercus brantii) Plants on the Healing of Skin Ulcers in Diabetic Patients - A Clinical Trial
Public title
The Effect of Hydroalcoholic Extracts of Yarrow, Felty Germander, and Oak Fruit Inner Bark on the Healing of Skin Ulcers in Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Wound area in the range of 0.5 to 36 cm2
Duration of infection more than 4 weeks
Age 18 or older
Exclusion criteria:
Participation in another similar research
Receipt of radiation or chemotherapy in recent times
Use of local growth factors or biomedicals for ulcer treatment in the last 30 days
Sensitivity to the used plants
Smoking or drug use
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization codes will be generated using the RAND function in Microsoft Excel and will be used for the assignment of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and statistical experts will remain blinded until the results are obtained and the statistical analyses are completed.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Yasuj University of Medical Sciences
Street address
Dr. Shahid Jalil St.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.YUMS.REC.1402.025
Health conditions studied
1
Description of health condition studied
Skin wound healing in diabetic patients
ICD-10 code
S01
ICD-10 code description
Open wound of head
Primary outcomes
1
Description
Percentage reduction in the area of diabetic ulcers
Timepoint
Up 3 weeks
Method of measurement
Ulcers will be measured in square centimeters using planimetry and photography.
Secondary outcomes
1
Description
Wound healing rate
Timepoint
Up 3 weeks
Method of measurement
Ulcers will be measured in square centimeters using planimetry and photography.
Intervention groups
1
Description
Intervention Group: Diabetic patients with diabetic ulcers receiving standard medications and herbal washing solution with daily consumption of a total concentration of 125 mg/ml of the extract of all three plants for three weeks.
Category
Treatment - Drugs
2
Description
Control group: Diabetic patients with diabetic ulcers receiving standard medications
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr Hassan Bardania
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Dr. Shahid Jalil St.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
hbardania@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Hassan Bardania
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Dr. Shahid Jalil St.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
hbardania@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Hassan Bardania
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Dr. Shahid Jalil St.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
hbardania@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
Undecided - It is not yet known if there will be 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
Yes - There is 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 and results related to the effect of the extract on patients' wounds (anonymously)
When the data will become available and for how long
Beginning of the access period from 1403
To whom data/document is available
Patients and specialists
Under which criteria data/document could be used
They will be available for other researchers, but we need the permission from the ethics committee of the university.
From where data/document is obtainable
Hassan Bardania
PhD of NanoBiotechnology
Cellular and Molecular Research Center,
Yasuj University of Medical Sciences
Yasuj, Iran
Email: hbardania@gmail.com
Tel: 09190854796
What processes are involved for a request to access data/document