To assess the effect of chamomile versus placebo on first-degree pressure ulcer in patients hospitalized at ICU
Design
This a double-blind randomized clinical trial, phase II, in which 64 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with first-degree pressure ulcer who will hospitalized in ICU at Azahra, Amin or Imam Hossein Hospitals during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years;
Hospitalized in ICU;
Having first-degree pressure ulcer;
Exclusion criteria:
A history of allergy or cutaneous hypersensitivity;
Any hypersensitivity to chamomile
Intervention groups
Intervention group: Topical ointment including chamomile active ingredient daily for 7 days
Control group: Topical ointment including placebo (Vaseline) daily for 7 days
Main outcome variables
Primary outcome: Improvement of ulcer on 4 and 7 days after intervention through physical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N205
Registration date:2018-02-03, 1396/11/14
Registration timing:registered_while_recruiting
Last update:2018-02-03, 1396/11/14
Update count:0
Registration date
2018-02-03, 1396/11/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of chamomile versus placebo on first-degree pressure ulcer in patients hospitalized in ICU: a double-blind randomized clinical trial
Public title
Effect of chamomile versus placebo on first-degree pressure ulcer in patients hospitalized in ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Hospitalized in ICU
Having first-degree pressure ulcer
Exclusion criteria:
A history of allergy or cutaneous hypersensitivity
Any hypersensitivity to chamomile
Age
From 18 years old to 70 months old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.IUMS.REC.1396.699
Health conditions studied
1
Description of health condition studied
Pressure ulcer
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Improvement of ulcer
Timepoint
On 4 and 7 days after intervention
Method of measurement
Through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical ointment including chamomile active ingredient daily for 7 days
Category
Treatment - Drugs
2
Description
Control group: Topical ointment including placebo (Vaseline) daily for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra Hospital
Full name of responsible person
Maryam Hashemi
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
m.hashemi690@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Ahmad Movahedian Attar
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Maryam Hashemi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
m.hashemi690@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Reza Yazdan Nik
Position
Ph.D. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
yazdannij@nm.mui.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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