Determination of effect of herbal ointment including Plantago major L and Rosa damascene on bed sore.
Design
The study is a community-based randomized clinical trial with parallel design (intervention and control), double blind controlled, randomized, one step. Sample size 100 (50 individuals per group) in which Individuals will be assigned into the intervention or control groups using a random number table (as a tool of randomization).
Settings and conduct
The subjects were patients with bed sores in Khomein city who have grade 2 and grade 3 ulcers. Blindness in this study was double-blind, so that the participant and researcher evaluated the outcome were not aware of allocation of the patients under study. In this study, the repair of compression wounds was compared with the two methods including dressing with herbal ointment (honey, Plantago major L and Rosa damascene) and dressing with Comfeel. Wound dressing in both groups were done under equal conditions (how many times the dressing is changed in 24 hours, the duration and manner of washing). PUSH is used as a data gathering tool. Before and after 4 weeks of intervention, the tool was measured and its scores were compared between two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years old; having 2nd and 3rd grade pressure ulcers.
Exclusion criteria: Any allergy to the use of plants; sores containing pus; bone involvement; bone visibility; sepsis due to wound infections.
Intervention groups
Intervention group: Intervention included placement of a layer of herbal ointment include Plantago major L and Rosa after washing and scrubbing the ulcer and covering with a layer of sterile gas.
Control group: placing a layer of Comfeel on the wound after washing and cleaning the wound and covering with a sterilized gas.
Main outcome variables
Wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100130003227N13
Registration date:2019-05-24, 1398/03/03
Registration timing:retrospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Ashraf Salehi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 5222 7550
Email address
salehi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
2019-04-17, 1398/01/28
Scientific title
Comparison of the effect of herbal ointment including Plantago major L and Rosa damascene on the bed sore of hospitalized patient
Public title
The effect of herbal ointment including Plantago major L and Rosa damascene on bed sore.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of over 18 years old
having 2nd and 3rd grade pressure ulcers
the same antibiotic use in all patients
Exclusion criteria:
any susceptibility to the use of herbs
certain vascular damage such as Burger disease
the presence of combined skin problems.
bone involvement
bone visibility
sepsis caused by wound infections
malignancy
connective tissue disease
Vasculitis
known case of immune system disorders
Corticosteroid use
chemotherapy
radiotherapy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be assigned into the intervention or control groups using a random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded for allocation into intervention or control groups due to randomization and will not be informed about the intervention type (Dressing with herbal ointment combing honey, tufted bell pepper and spinach or dressing with Comfeel, which is commonly used to repair bed litter.) before study initiation. Outcome assessors will not be informed about the patients categorization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Khomain University of Medical Sciences
Street address
Qods Blvd
City
Khomein
Province
Markazi
Postal code
38817-43364
Approval date
2018-03-18, 1396/12/27
Ethics committee reference number
IR.KHOMEIN.REC.1397.003
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound healing score according to the PUSH tool
Timepoint
Before and after 4 weeks of intervention
Method of measurement
PUSH tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention consists of placing a layer of herbal ointment consisting of honey, Plantago major L and Rosa damascene on the wound (bed sore) to the required amount (based on the size, amount and type of secretion of the wound), after washing and scrubbing (rinsing with 0.9% normal serum serum) Which was covered with a layer of sterilized gas. Wound dressing was carried out in both groups under equal conditions (number of dressing changes in 24 hours, duration and manner of washing). In this study, to prepare this ointment, 1.5 grams of the Plantago major L in 25 ml of water and 1 g of the Rosa damascene in 25 ml of water are brewed and mixed with 50 g of honey and For every dressing, was used. After preparing the ointment, pouring some ointment in a can for each patient and labeling the name of each patient on the can were done. Dressing was done by two trained observer (one man and one female) about the method of dressing the bed sore, one to three times a day (depending on the condition of the wound) until complete wound healing. Observers took an observation measure (PUSH: pressure ulcer score for healing) before the intervention and then every week at a specified hour to determine the instrument scores. The Braden tool was used to control the confounding factors such as patient mobility, sensory perception, skin moisture, degree of physical activity, and nutritional status of patients.
Category
Treatment - Other
2
Description
Control group: The intervention involves placing a layer of Comfeel on the wound (bed sore) to the required amount (based on the size, amount and type of secretion of the wound), after washing and scrubbing (rinsing with 0.9% normal serum serum) Which was covered with a layer of sterilized gas. Wound dressing was carried out in both groups under equal conditions (number of dressing changes in 24 hours, duration and manner of washing). Dressing was done by two trained observer (one man and one female) about the method of dressing the bed sore, one to three times a day (depending on the condition of the wound) until complete wound healing. Observers took an observation measure (PUSH: pressure ulcer score for healing) before the intervention and then every week at a specified hour to determine the instrument scores. The Braden tool was used to control the confounding factors such as patient mobility, sensory perception, skin moisture, degree of physical activity, and nutritional status of patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Mohhammad Taheri
Street address
Qods Blvd
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4633 2211
Email
rheum.nursing@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomain University of Medical Sciences
Full name of responsible person
Javad Javaheri
Street address
Qods Blvd
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
Javad.javaheri@khomeinums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomain 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
Khomein University of Medical Sciences
Full name of responsible person
Mohhammad Taheri
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qods Blvd.
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
rheum.nursing@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomain University of Medical Sciences
Full name of responsible person
Ashraf Salehi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qods Blvd.
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
najm54@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khomain University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qods Blvd.
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1533
Email
hamid52us@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A large amount of data, such as information on the main outcome, how to do it, and ... can be shared.
When the data will become available and for how long
Accessible 6 months after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
By observing ethics in research
From where data/document is obtainable
Hamid Momeni hamid52us@yahoo.com
What processes are involved for a request to access data/document
Sending the request to the email and waiting for the answer; applicant's authentication; sending an answer or response to the applicant after a scientific and ethical verification within a maximum of two weeks.