The effect of Marsh Mallow Ointment on Incontinence-associated dermatitis (IAD)
Design
This study is a randomized, double-blind, controlled clinical trial. 88 patients will be assigned randomly in two groups of drug and placebo.
Settings and conduct
The research will be carried out in the hospital wards of Shaheed Mostafa Khomeini Hospital. Before implementing the intervention; the researcher will complete the demographic information form and Incontinence-associated dermatitis and its severity (IADS) instrument. 88 patients will be assigned randomly in two groups of drug and placebo. In the drug and Placebo group, 1% Marsh Mallow Ointment and Vaseline will be used topically twice a day for seven days, respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria include Aged 60 years and up; the presence of Incontinence-associated dermatitis; having informed consent; the probability of hospitalization for 7 days;
Exclusion criteria include: Having sensitivity to drug; having any kind of infection, bruising, scratching or skin lesions at the treatment site
Intervention groups
Drug Group: In this group, 1% Marsh Mallow Ointment will be used topically twice a day for seven days.
Placebo group: In this group, vaseline (placebo) will be used topically twice a day for seven days.
Main outcome variables
incontinence associated Dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181121041711N1
Registration date:2019-05-27, 1398/03/06
Registration timing:registered_while_recruiting
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Zohreh Ghadiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5592 4860
Email address
ghadiri2835@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Marsh Mallow Ointment on Incontinence-associated dermatitis(IAD) in the elderly
Public title
Effect of Marsh Mallow Ointment on Incontinence associated dermatitis(IAD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 60 years and up
The presence of Incontinence - associated dermatitis
Having informed consent
The probability of hospitalization for 7 days
Exclusion criteria:
Having sensitivity to drug
Having any kind of infection, bruising, scratching or skin lesions at the treatment site
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Random allocation to drug and placebo groups
Block randomization is performed using 4 blocks, including 2 drugs and 2 placebos. Accordingly, 22 blocks are allocated to patients. In each block, there are two people in group A and two in group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo are encoded in similar containers. Participant, Clinician, Researcher, and outcome evaluator are not aware of the contents of the drug or placebo containers.
Measurement of the dermatitis in the beginning of the study (before starting the intervention) and from day 1-7 after starting taking Marsh Mallow.
Method of measurement
The Incontinence Asociated Dermatitis And Its Severity Instrument
Secondary outcomes
1
Description
Any observed adverse event
Timepoint
during treatment course
Method of measurement
Side effects check form
Intervention groups
1
Description
Drug group: Patients in this group used Marshmallow ointment extracted with ethanol and 1% concentration, used topically and in a thin layer, twice a day for seven days.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group use vaseline ointment (placebo) topically in the form of a thin layer twice a day for seven days.