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Investigating the effect of henna on the treatment of diabetic ulcers in patients with type 2 diabetes

Protocol summary

Study aim
Investigating the effect of henna in healing diabetic wounds in patients referred to clinics affiliated to Arak University of Medical Sciences
Design
A clinical trial with control and intervention groups, without blinding, on 66 patients.
Settings and conduct
The study is carried out in clinics affiliated to Arak University of Medical Sciences. The control group receives only normal saline, but the intervention group receives henna in addition to normal saline. First, 1 gram of henna powder leaves with 10 ml of distilled water is tested on the inner part of the forearm, if there is no sensitivity to henna extract, interventional treatment is started in the form that henna powder leaves are mixed with distilled water every 3 days, then for sterilization the composition, it is boiled for 10 minutes. After cooling, it is applied on the wound for 30 minutes and the results are evaluated after 15 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having type 2 diabetes At least 18 years old Exit criteria: Active wound infection The patient's unwillingness to participate in the study
Intervention groups
The control group receives only normal saline, but the intervention group receives henna in addition to normal saline. First, 1 gram of henna powder leaves with 10 ml of distilled water is tested on the inner part of the forearm, if there is no sensitivity to henna extract, interventional treatment is started in the form that henna powder leaves are mixed with distilled water every 3 days, then for sterilization the composition, it is boiled for 10 minutes. After cooling down, it is placed on the wound for 30 minutes.
Main outcome variables
Determining the severity of diabetic ulcer in the control and intervention groups before and after the intervention; Comparison of diabetic ulcer severity in the control and intervention groups before and after the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160220026667N7
Registration date: 2024-02-01, 1402/11/12
Registration timing: prospective

Last update: 2024-02-01, 1402/11/12
Update count: 0
Registration date
2024-02-01, 1402/11/12
Registrant information
Name
Ali Jadidi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3508
Email address
jadidi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of henna on the treatment of diabetic ulcers in patients with type 2 diabetes
Public title
Investigating the effect of henna on diabetic wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes At least 18 years old Living in Arak Willing to participate in the study No use of topical ointments
Exclusion criteria:
Active wound infection with clear purulent discharge or erythema of the wound margin or the presence of fever, radiographic clinical evidence of osteomyelitis Strong clinical evidence of serious insufficiency of lower limb circulation The patient's unwillingness to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.ARAKMU.REC.1402.023

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Diabetic ulcers
Timepoint
Before the intervention and 15 days after the intervention
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: use of normal saline and henna to wash the wound. First, one gram of henna powder leaf is tested with 10 ml of distilled water on the inner part of the forearm, and if there is no sensitivity to henna extract, interventional treatment is started. In this way, every three days, henna powder leaves are mixed with distilled water (ten milliliters of distilled water is added for each gram of henna powder leaves), then in order to sterilize the resulting mixture and destroy the microbes in it, It is boiled for 10 minutes. After cooling, the necessary amount (according to the size of the wound) is placed on the wound as a poultice for 30 minutes, and the results are evaluated after 15 days. Control group: use of normal saline to wash the wound
Category
Treatment - Drugs

2

Description
Control group: Only normal saline is used to wash the wound.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Ali Jadidi
Street address
Khorram Street, Shiroudi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3524 3417
Email
Jadidi.ali83@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Arak University of Medical Sciences
Street address
Sardasht, Basij Square, Prophet Azam University Complex, Faculty of Nursing
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3524 3417
Email
jadidi.ali83@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sardasht, Basij Square, Prophet Azam University Complex, Faculty of Nursing
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3524
Email
jadidi.ali83@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sardasht, Basij Square, Prophet Azam University Complex, Faculty of Nursing
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3524
Email
jadidi.ali83@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sardasht, Basij Square, Prophet Azam University Complex, Faculty of Nursing
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3524
Email
Jadidi.ali83@yahoo.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
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
Regarding the data file and the individual data of the participants, it should be said that only part of the data, such as the information related to the healing or non-healing of the wound due to the use of henna, can be shared.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
The scientific information of this study will be available to all interested and researchers.
Under which criteria data/document could be used
People are allowed to use information for research and information gathering.
From where data/document is obtainable
People can request access to information by email at jadidi.ali83@yahoo.com.
What processes are involved for a request to access data/document
After the publication of the article, people can access the information by searching in reliable databases, otherwise, if they contact the mentioned email, people can announce their request and get their answer as soon as possible.
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