Introduction
Rationale of
study
Acute tonsillitis is classified in ICD 11 MMS as Diagnosis code CA03
Acute tonsillitis is
defined as Acute inflammation of tonsils, accompanied by pain on swallowing, fever,
malaise and throat
pain. Tonsillitis occurs when
the trapped organisms penetrate the mucosal barrier and attach themselves to
the epithelial cells, leading to cytokine production and complement activation.
These events induce an inflammatory reaction in the tonsilarmucosa symptoms
include sore throat mild rise of temperature, Difficulty of deglutition ,Mild tenderness of lymph node
Epidemiological data
Tonsillitis is a common
condition among children worldwide, including in India. While specific statistics for India can vary, studies
suggest that tonsillitis affects about 10 to 30 percent
of children at some point in their childhood. The condition is most prevalent
in children between the ages of 5 and 15. Studies among children in India show
that the prevalence of asymptomatic throat carriage of group A streptococci ranges from 3.7percent to 20 percent ’Sore throat’
has an annual incidence of 100 in 1,000, with tonsillitis accounting for approximately 32 in 1,000
patients per year. In the current research, a survey on prevalence
of tonsillitis in adults was formulated .Approximately, 77 percent female are
affected with tonsillitis than 22.9 percent of male. Among the responders, 75
percent have tonsillitis and remaining 25 percent not.Homoeopathy, with its holistic
approach, offers a promising alternative for the treatment and prevention of tonsillitis. This system of
medicine emphasizes individualized treatment, targeting the root causes and
constitutional imbalances rather than just alleviating symptoms.
Homoeopathy also
focuses on managing the emotional and physical well being of the patient,
which can aid in faster recovery and better long-term outcomes.This study bridges the gap by assessing the
impact of effectiveness of individualized Homoeopathic medicine
in management of Acute Tonsilitis among 18 to 50 years of age
group.
Hence the study will be undertaken to understand the effectiveness of individualized Homeopathic management
of Acute tonsilitis
Objectives
Primary Objective To study Effectiveness
of Individualized homoeopathic medicine in management of Acute Tonsillitis among 18-50 years of age group.
Secondary Objective 1To compare the pre
and post treatment grade using the pre validated Brodsky grading scale of Acute
Tonsillitis.
Secondary Objective
2To compare
the pre and post treatment score using pre
validated VAS scale in Acute Tonsillitis.
Methodology
1.
Type of study Design An Experimental non-controlled study.
2.
Setting Cases will be collected
from the OPD of the institute.
3.
Duration of study
18 months
Method of Selection of Study Subjects
Inclusion criteria
1. Patients among 18
to 50 years of age group.
2. Patients of all genders.
3. Patients clinically diagnosed with acute tonsillitis.
4. Patients willing
to give informed
consent.
Exclusion criteria
1.Females who are pregnant
and lactating.
2.Cases with suspected
Immune compromised patients.
3.Patients with chronic tonsillitis, recurrent tonsillitis and associated complication such as peritonsillar abscess.
4.Patients who have takenother line of treatment in the past 3
months.
Subject withdrawal criteria
1.
Patients who withdraw
their consent to continue the homoeopathic
treatment further.
2. If any complications develops
during ongoing study.
3. Patients with irregular follow
up.
4. If any exclusion criteria
develops during treatment.
METHOD OF SELECTION
OF COMPARISON OR CONTROL GROUP Not Applicable
MATCHING CRITERIA:
Not
Applicable
Operational
Definition:
ACUTE TONSILITIS
ICD
11 MMS as Diagnosis code CA03
The common condition is characterised by a sore throat , fever, general malaise, dysphagia, enlarged upper cervical
nodes and sometime
referred otalgia.
INDIVIDUALIZED HOMOEOPATHIC MEDICINE
Aphorism 153
In this search for a homoeopathic specific remedy, that is
to say, in this
comparison of the collective symptoms of the natural disease with the list of
symptoms of known medicines, in order to find among these an artificial 18
morbific agent corresponding by similarity to the disease to be cured, the more
striking, singular, uncommon and peculiar signs and symptoms1 of the case of
disease are chiefly and most solely to be kept in view; for it is more
particularly these that very similar ones in the list of symptoms of the selected
medicine must correspond to, in order
to constitute it the most
suitable for effecting the cure. The more general and undefined
symptoms: loss of appetite,
headache, debility, restless
sleep, discomfort, and so forth, demand but little attention
when of that vague and indefinite character,
if they cannot be more accurately described, as symptoms of such a general nature are observed in almost
every disease and from almost every drug
Specification of instrument and related instrument
1. Standardized Case taking Proforma.
2. Outcome assessment tool.
Pre validated Brodsky Scale of Tonsil size
Grade 0 Tonsils in the fossa
Grade 1 Tonsils outside
of the fossa and occupy
less than equal to 25 percent
of the oropharyngeal width
Grade
2 Tonsil
occupy 26 to 50 percent of the oropharyngeal width
Grade 3 Tonsils occupy
51 to75 percent of the oropharyngeal width
Grade
4 Tonsils
occupy more than75 percent of the
oropharyngeal width
Pre
validated visual analog scale
PAIN INTENSITY CATEGORIES
Mild Score of 1 to 3
Moderate Score of 4 to 6
Severe Score of 7 to10
The Outcome
will be assessed
in terms of
Improved If Pre validated Brodsky
grading scale’s score & Pre validate VAS scale’s score is reduced than the previous
Prevalidated Brodsky grading
scale’s score & Pre validated VAS scale’s score,
after taking homeopathic medicines.
Not Improved If Pre validated Brodsky
grading scale’s score &
Pre validated VAS scale’s score remains same after taking homeopathic
medicines.
Research
methodology specified and explained for data collection
Sample Size total
sample size is 50
Sampling technique Non Probability Purposive Sampling Technique
Method for Data
Collection Relevant To Objectives
a.
Clinically diagnosed cases of Acute
Tonsillitis will be enrolled
from the regular patient pool of Out Patient Department of the Institute.
b.
Non-probability Purposive sampling based on Inclusion and Exclusion criteria will be
done.
c.
Detailed Homeopathic case taking will be done as per Clinical criteria.
d.
Pre validated Brodsky
scale score and Pre validated VAS scale score will be asses at the start of the study
e.
Patients will be given homeopathic medicine in appropriate doses and potency.
f.
Clinical out come assessment will be done at the
base of the2nd 4th & 6th day.
Study Instruments or Data Collection Tools
A. Standardized homeopathy case taking proforma
B. Pre validated Brodsky grading scale & Pre validated VAS scale will be used to assess the patient before
and after treatment.
C. Appropriate ENT instruments, such as Tongue depressor
and Torch will be used under natural light.
D. StandardHomoeopathicmateria
medical books, ENT books, surgery books, Different Homeopathic Journals,
research papers and articles, websites
will be considered.
E. Appropriate Homeopathic software will be used for Repertorization of Cases.
F. Informed Written
Consent of 50 patients of Acute Tonsillitis will be taken.
G. Patient information sheet will be provided.
Data Management And Analysis Procedure
1.
Framing of totality
of symptoms: Totality
will be framed
as per principles of homeopathy.
2.
Selection of remedy: Homeopathic medicines will
be selected after Repertorization& after
referring to Materia medica.
3.
The Posology: Potency
and repetition will be done as per the requirement of each patient.
Duration
A. Duration of study 18 months
B. Duration of each case 7 days or till the recovery occurs, whichever is earlier.
C. Duration of each follow-up every
2 days
D. Clinical
outcome assessment will be done at the base of the
2nd,4th & 6th day
Plan for statistical analysis
Statistical techniques
1.Data
collected will be compiled onto a MS Office excel worksheet &
will be subjected to statistical analysis using an appropriate package like SPSS software.
Descriptive statistics like frequency &
percentage of categorical, mean & 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 on the normality of data,
statistical tests will be determined.
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