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CTRI Number  CTRI/2024/01/061366 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   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 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NESA KUMAR A 
Designation  PhD Scholar 
Affiliation  SRI SAIRAM HOMOEOPATHY MEDICAL COLLEGE AND RESEARCH CENTRE 
Address  sairam college road, sai leo nagar, poonthandalam, west tambaram, chennai,
Dr.M.P.K Homoeopathic medical college and research centre Homoeopathy university Plot No 10,11,12 Saipura Sanganer Jaipur Rajasthan
Kancheepuram
TAMIL NADU
600044
India 
Phone  9003204587  
Fax    
Email  nesakumar0101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PRASOON CHOUDHARY 
Designation  PROFESSOR 
Affiliation  Dr.M.P.K Homoeopathic medical college and research centre 
Address  Dr.M.P.K Homoeopathic medical college and research centre Homoeopathy university Plot No 10,11,12 Saipura Sanganer Jaipur Rajasthan

Jaipur
RAJASTHAN
0141-2713026/30
India 
Phone  9414718100  
Fax    
Email  drprasoonchoudhary@gmail.com  
 
Details of Contact Person
Public Query  
Name  NESA KUMAR A 
Designation  PhD Scholar 
Affiliation  Dr.M.P.K Homoeopathic medical college and research centre 
Address  Dr.M.P.K Homoeopathic medical college and research centre Homoeopathy university Plot No 10,11,12 Saipura Sanganer Jaipur Rajasthan

Jaipur
RAJASTHAN
0141-2713026/30
India 
Phone  9003204587  
Fax    
Email  nesakumar0101@gmail.com  
 
Source of Monetary or Material Support  
Sri Sairam homoeopathy medical college and research centre Sai leao Nagar West tambaram Chennai - 600044 
 
Primary Sponsor  
Name  NESA KUMAR A 
Address  Sri Sairam homoeopathy medical college and research centre Sai leo nagar West tambaram Chennai 600044 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nesa Kumar   Sri Sairam homoeopathy medical college and research centre   Department of Forensic Medicine and Toxicology Block 3 Sai leo nagar West tambaram
Kancheepuram
TAMIL NADU 		 09003204587

nesakumar0101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indicated Homoeopathy medicines  Indicated homoeopathy medicines as per the case 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  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). 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  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 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction

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

Research question

                        Whether the indicated homoeopathic medicines helps to relieve the signs and symptoms of recurrent follicular tonsillitis.

Aims and Objectives

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

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

MATERIALS AND METHODOLOGY

STUDY SETTINGS

The study will be conducted in the paediatrics clinics operating in Sri Sairam  Homoeopathic Medical College,Tambaram, Chennai and Grace Homoeo Clinic Chennai. The clinics provide routine OPD care to patients suffering from Recurrent follicular tonsillitis using homoeopathic medicines only.

Study Duration:1 year 6 months

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

Study Design

 A clinical study                      

Selection of samples

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

 ELIGIBILITY CRITERIA:

Eligibility for study

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

Inclusion Criteria:

·         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).

Exclusion criteria

·         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

 INTERVENTIONS

Homeopathic Intervention

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

Selection of Tools

Indicated homoeopathic medicine as per symptom similarity would be selected on the basis of totality of symptoms, followed by repertorization.The drugs must be prescribed on the basis of symptom totality and justification of prescription must be recorded in the case taking proforma.

Selection of medicine and potency

Selection of medicine would be based on the presenting symptoms of the case and the totality of symptoms as outlined in the case recording proforma followed by repertorization. Only single simple medicines would be permitted to be used. The selected medicine would be prescribed in 30 potency at start of treatment as once a day. During the period of the study, the potency would be raised sequentially as per the need of the case, in pursuance with the homoeopathic principles. The 200 potency and higher potencies will be used as once a week.

OUTCOMES ASSESSMENT

·         Change in Visual Analog Scale, Global Assessment of Complaint and ORIDL

·         Change in Tonsillar Hypertrophy Grading Scale

Photographic record of lesions

The investigator will keep photographic record of the lesions of the cases. Prior permission from the patient will be taken for photography of the lesions. The identity of the patient will be concealed while taking the photographs. The photographs will be taken from the same angle and light settings at baseline and subsequent follow ups. Soft copy of the photographs will be maintained.

 

 

 
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