INTRODUCTION
Chronic
urticaria ICD 11 MMS CODE: EB00.1
Urticaria
is a vascular reaction of the skin marked by the transient appearance of
smooth, slightly elevated patches that are erythematous and that are often
associated with severe pruritus. Urticaria are red and raised
circular swelling or wheals on the skin surface. It can be as small as pinhead
or as large as a dinner plate accompanied with itching and sometimes sensation
of burning. The wheals usually disappear within minutes to hours , some people
get them each day for weeks when hives occur most days for more than 6 weeks
this is defined as chronic urticaria. Epidemiology
data: The prevalence of urticaria has been reported to be
2.1 % to 6.7 % in children and adolescents. A study in India recorded urticaria
in 2.5 % of children below 14 years of age.
AIM AND OBJECTIVES
Primary Objective To study the Effectiveness of
individualized homeopathic medicines in the management of chronic urticaria in
children 5-14 years. Other objective
To
evaluate pre and post clinical outcome of chronic urticaria by using score on
UAS7 in children 5-14 years.
To study the
commonly indicated remedies for chronic urticaria in children5-14 years.
MATERIALS
AND METHODOLOGY
TYPE OF STUDY
DESIGN: Experimental Non-Controlled
STUDY SETTING: Outpatient Department of the Institute of.
(OPD)
STUDY DURATION:
18 Months
STUDY POPULATION: Clinically diagnosed case of chronic urticaria in
children 5-14 years of age
METHODS OF
SELECTION OF STUDY SUBJECTS
Inclusion criteria:
Clinically diagnosed cases of chronic urticaria
Patients of 5 to 14 years of age
Patients of both sexes
Patients who are willing to give written
consent will be considered
Exclusion criteria
Patients who are suspected immunocompromised
Patients having any systemic disease.
Patients having
other conservative treatment for chronic Urticaria.
Patients who are taking any other medication for any
other aliment or for chronic urticaria in the last 3 months
Subject withdrawal criteria
Patients
not coming for the follow up regularly. Patients who are not taking their prescribed medicine
timely. Patients who are not willing to continue
the homoeopathic treatment further. Patients getting severe medicinal
aggravation.
Patients getting into complications of
chronic urticaria like Anaphylaxis. Patients who getting complication like
angioedema.
OPERATIONAL
DEFINATION
CHRONIC
URTICARIA ICD 11 MMS CODE: EB00.1
Spontaneous
urticaria is a disease characterized by daily or already eruption of
spontaneous weals, angioedema or both. In case of Chronic urticaria,
spontaneous urticaria lasting six weeks or more.
SPECIFICFICATION
OF INSTRUMENTS & RELATED MEASUREMENTS:
Urticaria
Activity Score (UAS7)
Homeopathic
case taking proforma will used in each case.
Outcome assessment tool:
Urticaria Activity Score (UAS7)
Patients will be taught to measure the
number of urticarial wheals
None: 0 Mild (<20 wheals/24 hrs): +1 Moderate (20-50 wheals/24 hrs): +2 Intense (>50 wheals/24 hrs or
large confluent areas of wheals): +3
Pruritus (Itch)
None: 0 Mild (present but not annoying or troublesome): +1 Moderate (troublesome but does
not interfere with normal daily activity or sleep): +2 Intense (severe, interferes with normal daily
activity or sleep): +3 Outcome assessment criteria Patients
will be taught to measure the number of urticarial wheals
Comparison of pre-treatment and post-
treatment with
Urticaria Activity Score (UAS7)
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SR. NO
|
RESULT
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SCORE
|
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1
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Improved
|
0-1
|
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2
|
Not improved
|
2-3
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SAMPLE SIZE: sample size
will be taken 38
SAMPLING TECHNIQUE: Non-Probability
Purposive Sampling.
METHODS OF DATA COLLECTION RELEVANT
TO OBJECTIVE informed consent will be taken
from patient/parents/guardian before taking each case. verbal consent
will be taken from child before each case. Assent will be
taken from child above age of 10 years. Non-Probability
Purposive Sampling will be taken.
STUDY INSTRUMENT/ DATA COLLECTION TOOLS Complete Homoeopathic Case taking proforma to form totality. Evaluate
pre and post clinical outcome of chronic urticaria by using score on UAS7 in
children. Appropriate reference books like Homoeopathic Materia Medica,
Medicine books, Organon books, Pathology books, different homoeopathic journals
and research papers will be considered. Appropriate Software will be used for repertorization of case. Assent
form and verbal consent will be taken from child before case taking
DATA MANAGEMENT AND ANALYSIS
PROCEDURE
1.Framing of totality of symptoms:
will be done as per of Homoeopathy.
2.Selection of remedy: Homoeopathic remedies will be given as and when required after referring Materia medica. 3.The Posology: Appropriate potency for each case will be selected
based on the susceptibility of each patient. Potency will be modified as and when required 4.Duration of Study a. Duration of study: 18
months b. Duration of each case: Each case
will be studied for 6 months or till relief of symptoms c. Duration of follow up: Each case
will be followed up after 24hr,3rd day and 7days or as and when
require 5.Clinical Outcome Assessment will be
done at base,1 month, 3 month, 6month of treatment
PLAN FOR STATISTICAL ANALYSIS:
1.Data collected will be
compiled on to a MS Office Excel worksheet and will be subjected to statistical
analysing using an appropriate package like SPSS (Statistical Package
for Social Sciences) software. Descriptive statistics like frequency (n) & (%)
of categorical data, mean and standard deviation of numerical data in each time
interval will be depicted.
2.Normality of numerical data will be checked using Shapiro- wilk test or Kolmogorov-Smirnov test. Depending upon normality of data, statistical tests will be
determined.
3.Intra group comparisons for a numerical
continuous data following a normal distribution will be done using paired t
test (for observation), else a non-parametric substitute like Wilcoxon
signed rank test (for 2 observation).Keeping alpha (Type I error) at 5% and beta (Type
II error) at 20%,
power at 80%, p<0.05 will be considered statistically significant.
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