Effectiveness Of Individualised Homoeopathic Medicines in Management of Chronic Urticaria in Children 5 To 14 Years – An Experimental Non-Controlled Study.

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)

   

SR. NO

RESULT

SCORE

|1

Improved

0-1

|2

Not improved

2-3

SAMPLE SIZE: sample size will be taken 38SAMPLING 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.