The comparison of effect of the topical product of Cassia fistula on diaper rash of infants in comparison with hydrocortisone: a double-blind clinical trial
A) The main goal of the plan
Determining the effect of Flos topical product on diaper inflammation in children, compared to treatment with hydrocortisone
b) Sub-objectives of the plan.
1 Investigating the effect of Flos topical product on the duration of treatment
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 168 patients. Randomization using permuted block randomization method will be used
Settings and conduct
The evaluation of people entering the study is done by a doctor specializing in children and infants
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Boys and girls under two years old
2. The presence of signs of diaper inflammation
Exit criteria:
1. Presence of atopic dermatitis and related underlying diseases and other skin diseases
2. Using other treatments related to diaper inflammation two weeks ago
3. Severe type or score higher than 3
4. Drug sensitivity
5. Diarrhea
6 oral use of antibiotics
Intervention groups
This study is a double-blind randomized clinical trial study with a control group and a parallel design. The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined.
Main outcome variables
ِِDuration of treatment; intensity of redness; extent of redness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230314057713N1
Registration date:2023-04-07, 1402/01/18
Registration timing:registered_while_recruiting
Last update:2023-04-07, 1402/01/18
Update count:0
Registration date
2023-04-07, 1402/01/18
Registrant information
Name
Mozafar Ekhlasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3422 4372
Email address
mozafareghlasi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2024-01-04, 1402/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of the topical product of Cassia fistula on diaper rash of infants in comparison with hydrocortisone: a double-blind clinical trial
Public title
The effect of cassia fistula product
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants under two years old age
Inflammation of diaper area
Exclusion criteria:
Atopic dermatitis and other skin dermatitis
Other diaper rash treatment from 2 weeks ago
Sever type or inflammation with above score 3
Drug sensivity
Diarrhea
Oral antibiotic consumption
Age
From 1 day old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the method of random permutation blocks. The size of the blocks is 4 and the ratio of drug to control (hydrocortisone ointment) in each group is equal (1:1).
In each block, random permutations of 4 combinations of Flos and hydrocortisone formulations are considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Cassia fistula product ointment and hydrocortisone will be packed and coded in a single form with the same consistency and color and smell (with the addition of color and essential oil) with the same label by a pharmaceutical specialist in the medicinal plant laboratory of the Iranian Medicine School of Babol. The only person who knows the nature of the drugs is the pharmacist who manufactures the drug. Random codes are written on the boxes containing the drug (floss/hydrocortisone product) and after assigning the drug to the patients, the relevant code is recorded on the patient's file. to be The opening of the codes will be done after the end of the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Keshavarz Street, University Square, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47754
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.256
Health conditions studied
1
Description of health condition studied
Inflammation of the diaper area
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of treatment
Timepoint
each day
Method of measurement
Counting days
2
Description
intensity of redness
Timepoint
Counting days
Method of measurement
diaper dermatitis severity index score
3
Description
The extent of redness
Timepoint
Counting days
Method of measurement
Percentage of diaper area
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined. According to the summary of studies, the average recovery period is 7 days. The patients were followed up every day according to the assistant's phone call with the mother and based on the changes with the initial examination, and according to the in-person examination by the assistant on the first, fourth and seventh days, the changes in the score index were measured at the beginning and then at the end of the treatment, and statistically, between Two groups are compared. The duration of treatment is also evaluated
Category
Treatment - Drugs
2
Description
Control group: The evaluation of people entering the study is done by a doctor specializing in children and infants, and in case of clinical suspicion that there is a severe disease and severe bacterial and fungal infections that have led to local inflammation (severe type or a score higher than 3 ) is removed from the study and is subjected to standard treatment. Every person who meets the criteria for entering the study is evaluated by an Iranian medical expert using the Ddsis tool (diaper dermatitis severity index score) in the first and subsequent visits and with this tool The score of the patient is determined. According to the summary of studies, the average recovery period is 7 days. The patients were followed up every day according to the assistant's phone call with the mother and based on the changes with the initial examination, and according to the in-person examination by the assistant on the first, fourth and seventh days, the changes in the score index were measured at the beginning and then at the end of the treatment, and statistically, between Two groups are compared. The duration of treatment is also evaluated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان کودکان امیر کلا بابل
Full name of responsible person
Dr. Iraj Mohammadzadeh
Street address
Children's Hospital, Dar al-Shafa street, Amirkola