Evaluation of the effect of gel containing pot marigoid (Calendula officinalis L.) and leaf Garden balsam(Lawsonia inermis) in the treatment of bed sores in patients in the intensive care ward of the Shahrekord Educational Hospital
Evaluation of the effect of gel containing Pot marigold (Calendula officinalis L.) and leaf Garden balsam (Lawsonia inermis) in the treatment of bed sores in patients in an intensive care ward of Shahrekord Educational Hospital
Design
A clinical trial with a control group, parallel groups, double-blind, randomized, phase 3 on 40 patients. RA software was used for randomization and blocking was used to match the groups.
Settings and conduct
Patients are selected from the hospitalized patients in the ICU ward of Hajar Hospital in Shahrekord according to the mentioned including and excluding criteria. This study will be conducted as a double-blind controlled clinical trial on patients with 1st and 2nd-degree bed sores. Eligible people who did not meet the exclusion criteria including underlying diseases, drug use, and sensitivity to the compounds used in this project, received the herbal gel and placebo gel.
They are randomly divided into two groups. Both topical compounds are prepared in the same size and color packaging with the consultation and cooperation of the pharmacy specialist. In this study, the patients, the outcome assessor, and the analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion:
Bed sore (Class 1-3)
The satisfaction of the patient
Exclusion: Suffering from chronic skin diseases, Discharge or transfer the patient to other medical centers during the study
Intervention groups
Intervention group: gel containing Pot marigold and leaf Garden balsam
Control group: Placebo gel
Main outcome variables
Independent: Gel containing Pot marigolds and leaf Garden balsam
Dependent: Bed-sore
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062349N1
Registration date:2024-08-15, 1403/05/25
Registration timing:prospective
Last update:2024-08-15, 1403/05/25
Update count:0
Registration date
2024-08-15, 1403/05/25
Registrant information
Name
Lotfolah Afzali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5654
Email address
afzali@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-31, 1403/06/10
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
2024-08-31, 1403/06/10
Actual recruitment end date
2024-10-31, 1403/08/10
Trial completion date
2024-11-01, 1403/08/11
Scientific title
Evaluation of the effect of gel containing pot marigoid (Calendula officinalis L.) and leaf Garden balsam(Lawsonia inermis) in the treatment of bed sores in patients in the intensive care ward of the Shahrekord Educational Hospital
Public title
Avaluation of the effect of gel containing pot marigoid (Calendula officinalis L.) and leaf Garden balsam(Lawsonia inermis) in the treatment of bed sores in patients in the intensive care ward of Shahrekord Educational Hospital
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
bed sores (class 1 - 3)
The satisfaction of the patients
Exclusion criteria:
Suffering from chronic skin disease
Discharge or transfer the patient to other medical centers during the study
Allergies and skin, food and drug sensitivity
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were entered into these groups randomly. Samples are grouped using RA software. The homogenization of the studied groups was based on the following variables: sex, age, type of wound, severity, and wound area.
Blinding (investigator's opinion)
Double blinded
Blinding description
Eligible participants who did not meet the exclusion criteria, such as underlying diseases, drug usage, and sensitivity to the compounds used in this project, were randomly assigned to either the gel containing pot marigold (Calendula officinalis L.) and leaf of Garden balsam (Lawsonia inermis), or the placebo gel group. Both topical compounds were prepared in the same size and color with the consultation and cooperation of a pharmacy specialist. The patients and the doctors will not know the type of medicine, and after the completion of the treatment plan, the identity of the medications will be revealed. This study will be conducted as a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88741
Approval date
2024-05-29, 1403/03/09
Ethics committee reference number
IR.SKUMS.MED.REC.1403.026
Health conditions studied
1
Description of health condition studied
Bedsore
ICD-10 code
A31.8
ICD-10 code description
Other mycobacterial infections
Primary outcomes
1
Description
Bedsore
Timepoint
Two months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gel containing Pot marigold (Calendula officinalis L.) and leaf Garden balsam (Lawsonia inermis). In this study, prepared gel from these two plants for one month is used topically daily twice . The score of the effect and characteristics of the wound is measured based on the PUSH standard criteria at the beginning of the study and at the end of each week. The data obtained of these four weeks' are compared.
Category
Diagnosis
2
Description
Control group: Placebo gel. In this study, prepared placebo gel from these two plants for one month is used topically daily twice. The score of the effect and characteristics of the wound is measured based on the PUSH standard criteria at the beginning of the study and at the end of each week. The data obtained of these four weeks' are compared.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care ward of Shahrekord Educational Hospital
Full name of responsible person
Lotfolah Afzali Borujeni
Street address
Shqhrekord University of Medicql Sciences, Kashani Blvd, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 913 382 6620
Email
afzali@skums.ac.ir
Web page address
https://researches.skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Omrani
Street address
Shashrekord University of Medical Sciences, KashanI Blvd, Shahrekord,
City
Shqhrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3335 1031
Email
Omrani@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Lotfollah Afzali
Position
Academic Staff
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahrekord Univ. of Med. Sci. Kashani Blvd, Shahrekord .
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 5654
Email
afzali@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lotfollah Afzali Brojeni
Position
Academic staff
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahrekord University of Medicql Sciences, Kashani Blvd, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881571347
Phone
+98 38 3335 1031
Email
afzali@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Lotfolah Afzali Borujeni
Position
Academic Staff
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahrekord Univ. of Med. Sci. Kashani Blvd, Shahrekord .
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 5654
Email
afzali@skums.ac.ir
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