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Evaluation of the effect of herbal supplement prepared from savory essential oil on diabetic wounds in patients with diabetic wounds

Protocol summary

Study aim
Determining the effectiveness of herbal supplement prepared from savory essential oil on diabetic wounds
Design
A clinical trial with a control group, with parallel, non-blind, simple randomized groups, phase 2-3 on 20 patients.
Settings and conduct
In Vali Asr hospital of Arak, the patient is treated for two months. Clinical trial with control group, with parallel, non-blind, simple randomized groups, phase 2-3 on 20 patients. Patients are randomly divided into two groups of 10 people. One group consists of routine care with routine treatment, and distilled water as placebo, and the second group consists of routine care with routine treatment plus savory essential oil.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Presence of diabetes mellitus, clinical findings indicating wound infection such as redness, swelling, and discharge, presence of ulcers in the extremities. Exclusion criteria: Chronic disease other than diabetes that affects wound healing, such as severe vascular disease, lupus, rheumatoid arthritis, burgers, and kidney failure.
Intervention groups
Rinse the wound with normal saline, spray savory essential oil on the wound with a spray, and then sterile gauze impregnated with savory essential oil is placed on the wound and bandaged. Depending on the patient's condition, this is a maximum of one or two times a day dressing of patients, and the next time a day dressing of standard treatment according to the specialized principles of treatment, wounds are bandaged. In the control group, in one of the daily dressings, after washing the wound with normal saline, it is sprayed on the wound with sterile distilled water and sprayed with sterile gas impregnated with distilled water.
Main outcome variables
The duration of treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161017030336N9
Registration date: 2022-01-23, 1400/11/03
Registration timing: registered_while_recruiting

Last update: 2022-01-23, 1400/11/03
Update count: 0
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
Ghasem Habibi
Name of organization / entity
Islamic azad university
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3208
Email address
dr.habibi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of herbal supplement prepared from savory essential oil on diabetic wounds in patients with diabetic wounds
Public title
The effect of savory essential oil on diabetic wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proven diabetes Clinical findings that indicate wound infection such as redness, swelling, and discharge Presence of ulcers in the extremities of patients Having a body mass index of 18 to 35 Having full consciousness upon entering the study
Exclusion criteria:
Drug and alcohol abuse Having a chronic disease other than diabetes that affects the healing process of wounds such as severe vascular disease, lupus, rheumatoid arthritis, burgers and kidney failure Consumption of immunosuppressants Cancer and the use of cytotoxic drugs
Age
From 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the fact that this plan is not blind, the control and intervention groups are selected by simple random method, so that patients are numbered in the order of admission to the hospital in numbers from one to twenty, the first 10 admitted group We consider the intervention and the second 10 admitted people are considered as the control group.
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 Islamic Azad University, Arak Branch
Street address
Imam Khomeini Square, Imam Khomeini Boulevard, 3 km of Khomeini Road, Amirkabir University Town
City
Arak
Province
Markazi
Postal code
3836119131
Approval date
2022-01-07, 1400/10/17
Ethics committee reference number
IR.IAU.ARAK.REC.1400.040

Health conditions studied

1

Description of health condition studied
Unspecified diabetes mellitus with peripheral circulatory complications
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

2

Description of health condition studied
Wound complication
ICD-10 code
T81.3
ICD-10 code description
Disruption of wound, not elsewhere classified

Primary outcomes

1

Description
Degree of diabetic foot ulcer
Timepoint
Before the intervention and every week for up to four weeks after the intervention
Method of measurement
The degree and depth of diabetic wounds in centimeters in both control and test groups are assessed by the researcher

2

Description
Duration of treatment
Timepoint
Before the intervention and every week for up to four weeks after the intervention
Method of measurement
The degree and depth of diabetic wounds in centimeters in both control and test groups are assessed by the researcher

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Washing the wound with normal saline, spraying safflower essential oil on the wound with a spray, and then sterile gauze impregnated with safflower essential oil is placed on the wound and bandaged. Depending on the patient's condition, this is a maximum of one or two times a day dressing of patients and the next time a day dressing of standard treatment according to the specialized principles of treatment, wounds are bandaged
Category
Treatment - Drugs

2

Description
Control group: Rinse the wound with normal saline, spray sterile distilled water on the wound with a sprayer, and then sterile gauze soaked in sterile distilled water is placed on the wound and bandaged. Depending on the patient's condition, this is a once-daily dressing of the patients, and the next time the dressing is applied from the standard treatment according to the specialized principles of treatment, the wounds are bandaged.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital, Arak
Full name of responsible person
ِDr.Saeed Heidari
Street address
Valiasr Square, Valiasr Hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
heidari_65@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farane Zar Afshan
Street address
Arak - Imam Khomeini Square - Imam Khomeini Boulevard - 3 km of Khomeini Road - Amirkabir University Town - Vice Chancellor for Research and Technology, Center for Growth and Technology
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
fzarafshan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Ghasem Habibi
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Arak - Imam Khomeini Square - Imam Khomeini Boulevard - 3 km of Khomeini Road - Amirkabir University Town Growth and Technology Center
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
ghasemhabibi.chem@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Bandarian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
General Practitioner
Street address
North Kargar St., Shahrivar St., corner of Hiyat St., Diabetes Clinic, Floor 5, Diabetes Research Center
City
Tehran
Province
Tehran
Postal code
1441716411
Phone
+98 21 8833 8742
Email
fbandarian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghasem Habibi
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Arak - Imam Khomeini Square - Imam Khomeini Boulevard - 3 km of Khomeini Road - Amirkabir University Town Growth and Technology Center
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
ghasemhabibi.chem@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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