| CTRI Number |
CTRI/2025/08/093542 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Screening
Other (Specify) [Expermental Open Label] |
| Study Design |
Other |
|
Public Title of Study
|
The effectiveness of homoeopathic medicines in chronic tonsillitis among children aged 5-15 years: a study based on totality of symptoms and miasmatic analysis |
|
Scientific Title of Study
|
The effectiveness of homoeopathic medicines in chronic tonsillitis among children aged 5-15 years: a study based on totality of symptoms and miasmatic analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhawana Kumari |
| Designation |
MD PGR (Post Graduate Resident) |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur
Department of Organon of Medicine and Homoeopathic Philosophy Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8114437316 |
| Fax |
000000 |
| Email |
Bhawanajat672@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Jabdoliya |
| Designation |
Associate Professor Department of Organon of Medicine |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur
Department of Organon of Medicine and Homoeopathic Philosophy Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9782910856 |
| Fax |
0000 |
| Email |
harish10jabdoliya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Jabdoliya |
| Designation |
Associate Professor Department of Organon of Medicine |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur
Department of Organon of Medicine and Homoeopathic Philosophy Swasthya Kalyan Homoeopathic Medical College & Research Centre Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9782910856 |
| Fax |
0000 |
| Email |
harish10jabdoliya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College & Research Centre 10 A Sitapura Institutional Area Tonk Road Goner Road, Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022
|
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College & Research Centre |
| Address |
10 A Sitapura Institutional Area Tonk Road Goner Road, Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022 |
| 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 |
| Bhawana Kumari |
Swasthya Kalyan Homoeopathic Medical College and Research Center |
10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022
Jaipur
RAJASTHAN |
8114437316
00
bhawanajat672@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKHMCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J351||Hypertrophy of tonsils, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medines |
2/UA/HPM/2011 Oral route Doses and frequency will be according to the susceptibility of Patients and follow up in 15 days and total duration will be 3 Month |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes, aged between 5 to 15 years
Clinically diagnosed cases of chronic tonsillitis
Patients willing to participate and give informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with acute tonsillitis at the time of enrollment.
Patients undergoing conventional (allopathic) treatment for tonsillitis.
Patients unwilling to comply with follow-up.
Cases with immuno-suppressive diseases, Autoimmune Diseases, Advanced pathology with complication requiring other modes of treatment.
Children below 5 age group & above 15 years of age .
Cases which require emergency treatment. Refer to MoU
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Informal assessment Regular followup assessment by Guide |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will help to assess effectiveness of homoeopathic medicines in cases of chronic tonsillitis among Children Aged 5-15 Years. |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/09/2025 |
| 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 Applicable |
| 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
|
The study will
help to assess effectiveness of homoeopathic medicines in cases of chronic
tonsillitis among Children Aged 5-15 Years.The study will help to assess the predominant miasm in
cases of chronic tonsillitis.The study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Research Center Jaipur. |