Evaluation of efficacy of herbal ointment containing aqueous extract Scrophularia Straita Boiss, Honey , Sativa Nigella oil ,Mazo, Apple Vinegar in treatment of ulcers diabetes
Evaluation of efficacy of herbal ointment containing aqueous extract Scrophularia Straita Boiss, Honey , Sativa Nigella oil ,Mazo, Apple Vinegar in treatment of ulcers diabetes
Design
This study is a clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients.
Settings and conduct
This study is performed in patients referred to Imam Reza Hospital and Imam Khomeini Hospital in Kermanshah. Blinding is done for all patients and clinical caregivers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with diabetic ulcer
Exclusion criteria: Pregnant women - Children - People undergoing chemotherapy - People receiving corticosteroids. - Patients suffering from liver and kidney failure.
Intervention groups
In the intervention group, wound treatment with ointment, herbal detergent and routine dressing
In the control group, perform routine puncture and wound routine
Main outcome variables
Wound severity
Wound area
Wound site
Wound depth
Exodus
Type of texture
Pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201213049703N1
Registration date:2021-02-10, 1399/11/22
Registration timing:prospective
Last update:2021-02-10, 1399/11/22
Update count:0
Registration date
2021-02-10, 1399/11/22
Registrant information
Name
Toraj Ahmadi Jouybari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3727 2049
Email address
t.ahmadijouybari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of herbal ointment containing aqueous extract Scrophularia Straita Boiss, Honey , Sativa Nigella oil ,Mazo, Apple Vinegar in treatment of ulcers diabetes
Public title
Effect of herbal ointment in treatment of ulcers diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic ulcers
Exclusion criteria:
Pregnant women
Patients suffering from liver and kidney failure
Childern
People undergoing chemotherapy
People receiving corticosteroids.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization and assigning people to groups The random number function is used using Excel software as follows: First, in a column, the groups are entered as A, B and below. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, random numbers are generated from small to large or vice versa, which causes the order of the groups, A, B, to be changed. Using the new order, people are assigned to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Herbal ointments and routine treatment ointments are designed to be the same in terms of color and odor so that they are not recognizable to the patient and the caregiver. And only the statistical analyst should be aware of the ointment used.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.KUMS.REC.1399.073
Health conditions studied
1
Description of health condition studied
Ulcers diabetes
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
Description
PUSH Score
Timepoint
Every week until the 12th week
Method of measurement
Based on the characteristics of diabetic ulcers
Secondary outcomes
1
Description
Wound area
Timepoint
Every week until the 12th week
Method of measurement
With a caliper, the dimensions of the wound, including the length and width of the wound, are measured and its area is calculated
2
Description
Wound depth
Timepoint
Every week until the 12th week
Method of measurement
Wound depth is measured with forceps and calipers
Intervention groups
1
Description
The herbal ointment of the design containing thirsty plant extract, honey, black seed oil, mazo will be provided to the patients of the intervention group in the form of ready-to-use tubes without printing of the design. Contains thirst extract, apple cider vinegar and normal saline, washed and dried with sterile gauze. The herbal ointment is then applied to the wound with a watering can and fixed with a four-layer sterile dry gauze with anti-allergy adhesive. Changing the dressing and using the ointment should be done once a day for the necessary time. (Depending on the patient's condition until complete treatment)
Category
Treatment - Other
2
Description
Liam topical ointment (manufacturer of Mehr Miracle Researchers) containing chamomile extract, 8% cow's eye, 13% beeswax and 17% honey as a routine ointment of Imam Khomeini Hospital in Kermanshah in the form of ready-to-use tubes without printing. Patients in intervention group 2 will be included. The procedure will be performed by washing the wound and surrounding tissues with normal saline solution and drying them with sterile gauze. Liam ointment is then applied to the wound with a watering can and fixed with a four-layer sterile dry gauze with anti-allergy adhesive. Changing the dressing and using the ointment should be done once a day for the necessary time. (Depending on the patient's condition until complete treatment)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Toraj Ahmadi Jouybari
Street address
Kermanshah -Naghlieh Ave- Imam Khomeini Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 2049
Email
dr.ahmadi_jourbari@yahoo.co
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Toraj Ahmadi Jouybari
Street address
Kermanshah -Parastar Blvd- Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6307
Email
dr.ahmadi_jourbari@yahoo.co
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza KhodaRahmi
Street address
Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
rkhodarahmi@mbrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?