Determination of the Effect of Chamomile Extract on Prevention of Skin Complications ostomy
Design
A clinical trial with a control group, with a parallel group, one blind, randomized
Settings and conduct
The study in the Korosh Clinic of Isfahan is done on ostomy patients. In order to blind patients, containers containing an extract and placebo are same
Participants/Inclusion and exclusion criteria
The study population included all patients with colostomy and Ileostomy who had been operated less than 2 months ago
Intervention groups
Rubbing chamomile extract on the skin around the stoma in the intervention group and rubbing distilled water in the control group
Main outcome variables
Determining the frequency of ulcers in the skin around the stoma in the test and control group؛ Determine the frequency of types of secretions in the skin around the osteomy in the test and control group ؛ Determine the frequency of skin color changes around the osteomy in the test and control group
General information
Reason for update
Acronym
ECOS
IRCT registration information
IRCT registration number:IRCT20180802040674N1
Registration date:2018-09-22, 1397/06/31
Registration timing:registered_while_recruiting
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Abbas Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 2781
Email address
ravabet@ems.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-15, 1397/06/24
Expected recruitment end date
2018-11-15, 1397/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Chamomile Extract on Prevention of Stoma Dermal Complications
Public title
The Effect of Chamomile Extract on Stomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with colostomy or ileostomy who had surgery for less than 2 months
save Ostmy for the patient at least 2 months
If chemotherapy or radiation therapy has been at least 7 weeks since the last treatment period
Exclusion criteria:
skin Complications include: wound, inflammation and secretion of skin around the ostomy
History of chemotherapy or radiation therapy in the last 50 days
History of skin diseases including allergic disorders, skin allergy, Psoriasis, Candidiasis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to the clinic will be divided into two intervention and control groups with the random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The container containing essential oil and placebo will be the same for both groups of intervention and control And ET nurse will not be informed of the type of patients.
.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
3th of Qotb –e Ravandi Blvd., Kashan., IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.019
Health conditions studied
1
Description of health condition studied
ostomy skin complications
ICD-10 code
L23.1
ICD-10 code description
Allergic contact dermatitis due to adhesives
Primary outcomes
1
Description
Complications of the skin around the stomy
Timepoint
Skin complications around the stoma will be observe before the study and 7, 14, 21, and 28 days after the study
Method of measurement
Using a researcher-made tool
Secondary outcomes
1
Description
Skin Complications
Timepoint
will be observe before the study and 7, 14, 21, and 28 days after the study
Method of measurement
The tool is a researcher made
Intervention groups
1
Description
Intervention group: Use Chamomile extract that made in barij co. on the skin around the stomy after each change ostomy bag for one month.
Category
Prevention
2
Description
Control group: In this group, distilled water is used as a placebo in essential oil containers.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kourosh Specialized Clinic of Health and Diabetes
Full name of responsible person
Dr. Hosseini Muhammad
Street address
Sheikh Mofid st.
City
Isfahan
Province
Isfehan
Postal code
8154658781
Phone
+98 31 3664 3445
Fax
+98 31 3664 3445
Email
kouroshclinik@yahoo.com
Web page address
http://www.kouroshclinic.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidi Gholamali
Street address
3th of Qotb –e Ravandi Blvd., Kashan., IRAN
City
Isfahan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
hamidi_gh@kaums.ac.ir
Web page address
http://research.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Esfahan University of Medical Sciences
Full name of responsible person
َAbedi Abbas
Position
Paramedic
Latest degree
Bachelor
Other areas of specialty/work
Emergency Medical Services
Street address
Hezar Jarib st, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3273 1060
Email
abbasabedi2006@yahoo.com
Web page address
https://mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abedi Abbas
Position
Paramedic
Latest degree
Bachelor
Other areas of specialty/work
Emergency Medical Services
Street address
Isfahan Medical University, Hezar Jarib st.Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3273 1060
Email
abbasabedi2006@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abedi Abbas
Position
Paramedic
Latest degree
Bachelor
Other areas of specialty/work
Emergency Medical Services
Street address
Isfahan Medical University, Hezar Jarib st.Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3273 1060
Email
abbasabedi2006@yahoo.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
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