Effectiveness Of Individualized Homoeopathic Medicine In Management Of Acute Tonsilitis Among 18 to 50 Years Of Age Group An Experimental Non Controlled Study

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 tonsilarmucosasymptoms 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.      SettingCases will be collected from the OPD of the institute.

Duration of study18 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

PAININTENSITYCATEGORIES

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.

DataManagementAndAnalysisProcedure

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.