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CTRI Number  CTRI/2024/05/067135 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathy in Tonsillitis 
Scientific Title of Study   Utility of Homoeopathic Medical Repertory by Dr. Robin Murphy in Management of Cases of Tonsillitis 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemangi Rohitbhai Variya 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9727990201  
Fax    
Email  hemangi678@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hiral Kashyapbhai Trivedi 
Designation  Assistant Professor 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  7405820224  
Fax    
Email  hiral.trivedi1994@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemangi Rohitbhai Variya 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case taking and Repertory, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9727990201  
Fax    
Email  hemangi678@gmail.com  
 
Source of Monetary or Material Support  
Rajkot Homoeopathic Medical College 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College 
Address  Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot 
Type of Sponsor  Private medical college 
 
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 
Dr Hemangi Variya  Rajkot Homoeopathic Medical College  Department of Repertory, Rajkot Homoeopathic Medical College, behind jainath complex makkam chowk gondal road
Rajkot
GUJARAT 		 9727990201

hemangi678@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J03||Acute tonsillitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Individualized homoeopathic medicine selected using Homoeopathic Medical Repertory by Dr. Robin Murphy. Mode of Administration: Oral (sublingual) Selection of potency, dose and repetition : individualised medicine will be presecribed in 30, 200, 1 M potency. selection of dosage, potency and repitition will be according to susceptibility of patient and principles of organon of medicine 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  patients of both sexes and age group between 3 to 45 years
all socio economic classes irrespective of religion and caste will be considered
pre diagnosed or recently diagnosed cases having no improvement or relief after treatment
cases coming under Centor criteria or with clinical presentation of tonsillitis. 
 
ExclusionCriteria 
Details  complicated cases with advanced and irreversible pathological condition.
patients less then age of 3 years and more then 45 years of both sexes. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
There will be some improvement after prescribing Homoeopathic Medicines  There will be some improvement after prescribing Homoeopathic Medicines after 3 days, 5 days and 1 week. 
 
Secondary Outcome  
Outcome  TimePoints 
o Significant Improvement: - Patients with sense of well being with decrease in score between 0 to 1, without any complications and disappearance of signs and symptoms for which patient came to us, without relapse or recurrence during study duration.
o Moderate Improvement: - Patients have relief in symptoms with decrease in score, frequency and intensity of episodes of disease.
o Not improved or Status Quo: - There is no considerable change observed in complaints and no decrease in score even after administration of homoeopathic similimum. 		 there will be some improvement after prescribing homoeopathic medicines after 9 months. 
 
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)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
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  

               Tonsillitis is the term used for inflammation of the tonsils, two oval shaped pads of tissue at the back of the throat-one tonsil on each side.  Palatine tonsils are tissue situated in lateral wall of oropharynx between anterior and posterior pillars. Tonsillitis or inflammation of tonsils is common disease and makes approximately 1.3% of outpatient visits. It is 3rd infectious ENT pathology after rhinopharynigitis and otitis.

               Tonsillitis is condition that is commonly encountered in primary care and is the significant economic burden, with 35,000,000 days lost from work or school. There are about 75,55,494 insatances of tonsillitis in India each year.

               The mainstay of treatment of acute tonsillitis is supportive care, including analgesia and hydration. Medications such as NSAIDS can provide symptomatic relief and patient rarely requires hospitalization. Treatment may be surgical including tonsillectomy or tonisllotomy. Around 2,00,000 tonsillectomies are acted in India per year.

               Homoeopathy depends on Nature’s Law “Similia Similibus Curantur” which means let likes be treated by likes. Tonsillitis can be cured with help of Homoeopathic Medicines with permanent restoration of health. In many sever cases of recureent and chronic tonsillitis where tonsillectomy is advised, Homoeopathic medicines play a great role and surgical intervention can be avoided.

               For this study, I intend to select Homoeopathic Medicines on basis of Homoeopathic Medical Repertory by Dr. Robin Murphy in cases of Tonsillitis. Homoeopathic Medical Repertory by Dr. Robin Murphy is a modern alphabetical repertory which represents the experimental and therapeutic database for the practice of Homoeopathic Medicine.

 
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