| CTRI Number |
CTRI/2025/08/093776 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
AN INTERVENTIONAL STUDY TO ASCERTAIN THE
EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC
MEDICINES IN CASES OF TONSILLITIS IN PAEDIATRIC
AGE GROUP |
|
Scientific Title of Study
|
An Interventional Study To Ascertain The Effectiveness Of Individualized Homoeopathic Medicines In the Management Of Tonsillitis In Paediatric Age Group
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Wadia |
| Designation |
Post Graduate Resident |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic College and Research Cenrte 10 A Institutional Area Tonk road Sitapura Jaipur
Swasthya Kalyan Homeopathic and Research Centre 10 A Institutional Area Tonk road Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
09351516324 |
| Fax |
|
| Email |
dikshawa9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shobha Teterwal |
| Designation |
HOD Professor |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
Department of Paediatrics
Swasthya kalyan homeopathic and research centre Jaipur
Department of Paediatrics
Swasthya kalyan homeopathic and research centre Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7976638807 |
| Fax |
|
| Email |
Shobhateterwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shobha Teterwal |
| Designation |
HOD Professor |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
Department of Paediatrics
Swasthya kalyan homeopathic and research centre Jaipur
Department of Paediatrics
Swasthya kalyan homeopathic and research centre Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7976638807 |
| Fax |
|
| Email |
Shobhateterwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homeopathic and Research Centre 10 A Institutional Area Tonk road Sitapura Jaipur, Rajasthn,302022 |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homeopathic and Research Centre |
| Address |
Swasthya Kalyan Homeopathic and Research Centre 10 A Institutional Area Tonk road Sitapura Jaipur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Diksha Wadia |
Swasthya Kalyan Homoeopathic College and Research centre |
Swasthya Kalyan Homoeopathic College and Research Cenrte 10 A Institutional Area Tonk road Sitapura Jaipur
Swasthya Kalyan Homeopathic and Research Centre 10 A Institutional Area Tonk road Sitapura Jaipur
Jaipur
RAJASTHAN |
09351516324
dikshawa9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya Kalyan Homeoepathic Medical College institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicines |
1 Individualized Homoeopathic medicines will be selected with the help of repertory and
given according to the Homoeopathic Principals.
2. Potency and Dosage: selection of potency & dosage as per susceptibility of the patient.
Manufacturer- Medicine will be obtained from a GMP certified company.
3. Route of administration- Oral |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient coming from other mode of treatment with no relief. |
|
| ExclusionCriteria |
| Details |
1. Cases which require emergency treatment.
2. Above 18 years age group will be excluded.
3. Cases which need surgical intervention.
4. Immuno compromised patient such as suffering from HIV, Hepatitis B/C etc.
5. The study will excluded the cases with multi systemic illness and advance pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Homoeopathic management will be proven beneficial in the treatment of tonsillitis in Paediatric age group |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will help to develop and implement strategy in Homoepathic management of
tonsillitis. |
12 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)
|
06/09/2025 |
| 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="0"
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
|
This study is an interventional study to ascertain the effectiveness of individualized Homoeopathic medicines in cases of tonsillitis in Paediatric age group. The study will be conducted at OPD/IPD of the Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur. primary outcome of the study is that The Homoeopathic management will be proven beneficial in the treatment of tonsillitis in Paediatric age group. The study will help to develop and implement strategy in Homoepathic management of tonsillitis. Primary objective is to ascertain the effectiveness of individualized Homoeopathic medicine in cases of Tonsillitis in Paediatric age group. Secondary objective is to observe the age incidence of Tonsillitis in Paediatric age group. |