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临床试验/CTRI/2024/01/061366
CTRI/2024/01/061366尚未招募不适用

To ascertain the efficacy of homoeopathic medicines in the case of recurrent follicular tonsillitis in pediatric age group (5-10 yrs) with the help of tonsillar hypertrophy grading scale- A clinical study

NESA KUMAR A1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To understand the effectiveness of homoeopathic medicines in the case of recurrent follicular tonsillitis in pediatric age group (5-10 yrs) with the help of tonsillar hypertrophy grading scale - A clinical study

研究概览

简要总结

Introduction

Tonsillitisis an upper respiratory tract infection prevalent in school-aged children.Because this condition is self-limiting, conventional treatment options areusually palliative. Homeopathic remedies are a useful alternative toconventional medications in uncomplicated upper respiratory tract infections inchildren, offering earlier symptom resolution, cost-effectiveness, and easy totake. This study aimed to evaluate response of individualised Homoeopathictreatment in Recurrent folliculartonsillitis in paediatric age group

Researchquestion

Whether the indicatedhomoeopathic medicines helps to relieve the signs and symptoms of recurrentfollicular tonsillitis.

Aims and Objectives

Aim- Thisstudy aimed to evaluate response of individualized Homoeopathic treatment inrecurrent follicular Tonsillitis in pediatric age group(5-10 yrs).

Objectives- To assess the changes in Tonsillar Hypertrophy Grading Scale and Globalassessment of Complaints.

MATERIALS AND METHODOLOGY

STUDY SETTINGS

Thestudy will be conducted in the paediatrics clinics operating in Sri Sairam  Homoeopathic Medical College,Tambaram, Chennaiand Grace Homoeo Clinic Chennai. The clinics provide routine OPD care topatients suffering from Recurrent follicular tonsillitis using homoeopathicmedicines only.

**StudyDuration:**1year 6 months

  • One year-  Enrollment
  • Six months - Follow up
  • Two months - Data Compilation and Analysis

StudyDesign

A clinical study

Selectionof samples

40cases will be selected for the study as per the inclusion and exclusioncriteria as stated below

ELIGIBILITY CRITERIA:

Eligibility for study

  • Ages:   5-10yrs
  • Sex   : Both male and female

Inclusion Criteria:

·        Recurrent attacks of sorethroat or acute tonsillitis.

·        Chronic irritation inthroat with cough.

·        Bad taste in mouth andfoul breath (halitosis) due to pus in crypts.

·        Thick speech, Difficultyin swallowing and choking spells at night (when tonsils are large andobstructive).

Exclusion criteria

·        Use of Antibiotics treatment forTonsillitis in past 08 weeks

·        Age below 5 years and above 15 years

·        Any other systemic illness.

·        Any other infectious disease

INTERVENTIONS

Homeopathic Intervention

Homoeopathicdrugs as detailed in the standard Homoeopathic Materia Medica and in theHomoeopathic Pharmacopoeia (India/US) will be used in the study on the basis ofsymptom similarity (Homoeopathic principle). The drugs identified for the trialshall be procured from a GMP compliant pharmaceutical. Medicines will bedispensed in sugar globules of standard size 30.

Selection of Tools

Indicatedhomoeopathic medicine as per symptom similarity would be selected on the basisof totality of symptoms, followed by repertorization.The drugs must beprescribed on the basis of symptom totality and justification of prescriptionmust be recorded in the case taking proforma.

Selection of medicine and potency

Selection ofmedicine would be based on the presenting symptoms of the case and the totalityof symptoms as outlined in the case recording proforma followed byrepertorization. Only single simple medicines would be permitted to be used.The selected medicine would be prescribed in 30 potency at start of treatmentas once a day. During the period of the study, the potency would be raisedsequentially as per the need of the case, in pursuance with the homoeopathicprinciples. The 200 potency and higher potencies will be used as once a week.

OUTCOMES ASSESSMENT

·        Change in Visual Analog Scale, GlobalAssessment of Complaint and ORIDL

·        Change in Tonsillar Hypertrophy GradingScale

Photographic record of lesions

Theinvestigator will keep photographic record of the lesions of the cases. Priorpermission from the patient will be taken for photography of the lesions. Theidentity of the patient will be concealed while taking the photographs. Thephotographs will be taken from the same angle and light settings at baselineand subsequent follow ups. Soft copy of the photographs will be maintained.

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Recurrent attacks of sore throat or acute tonsillitis Chronic irritation in throat with cough Bad taste in mouth and foul breath(Halitosis) due to pus in crypts Thick speech, difficulty in swallowing and choking spells at night (when tonsils are large and obstructive).

排除标准

  • Use of antibiotics treatment for tonsillitis in past 08 weeks Age below 5 years and above 15 years Any other systemic illness Any other infectious disease.

结局指标

主要结局

To understand the effectiveness of homoeopathic medicines in the case of recurrent follicular tonsillitis in pediatric age group (5-10 yrs) with the help of tonsillar hypertrophy grading scale - A clinical study

时间窗: To understand the effectiveness of homoeopathic medicines in the case of recurrent follicular tonsillitis in pediatric age group (5-10 yrs) with the help of tonsillar hypertrophy grading scale - A clinical study

次要结局

  • To explain the effectiveness of homoeopathic medicines in follicular tonsillitis & to bring awareness among the general public consuming too much of antibiotics for follicular tonsillitis(24 weeks)

研究者

发起方
NESA KUMAR A
申办方类型
Other []

研究点 (1)

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