| CTRI Number |
CTRI/2025/09/094834 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Utility of Boger Boenninghausen’s Characteristics and
Repertory in Cases of Tonsillitis |
|
Scientific Title of Study
|
Clinical Utility of Boger Boenninghausen’s Characteristics and
Repertory in Cases of Tonsillitis Using Brodsky Grading Scale & Numerical Pain
Rating Scale |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitarth Modi |
| Designation |
PG Scholar |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room no.5,Department of Homeopathic medicine and surgery, Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
8200281405 |
| Fax |
|
| Email |
drhitarthmodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Shah |
| Designation |
HOD and Professor of Department Homoeopathic Repertory and Case taking |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room no.5,Department of Homeopathic medicine and surgery, Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
390018
India |
| Phone |
9327226888 |
| Fax |
|
| Email |
nikirhomoeotimes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitarth Modi |
| Designation |
PG Scholar |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room no.5,Department of Homeopathic medicine and surgery,Department of homoeopathic medicine Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar baug, Bhalej Road opp.new bus stand Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
8200281405 |
| Fax |
|
| Email |
drhitarthmodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Hitarth Modi |
| Address |
5/19 talav gate, Prestige apartment 4th floor Junagadh Gujarat-362001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Hitarth Modi |
Anand Homoeopathic Hospital |
Room no.5,Department of Homeopathic medicine and surgery Opp. Sardar baug, Nr. New Bus stand, Anand, Gujarat, Anand, Gujarat 388001, India
Anand
GUJARAT |
8200281405
drhitarthmodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
The medicine will be prescribed after doing repertorization with the help of BBCR and final choice will be made with the help of Materia Medica. The potencies 6C,30C,200C,1M etc. will be selected depending upon the susceptibility of the patient. The remedy will be repeated as per the requirement of the case. Medicine will be given orally.The duration of study is of 18 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A. All the cases of males and females belonging to age group above 5 years suffering
from acute or chronic tonsillitis will be included in this study.
B. Patients with confirmed diagnosis of tonsillitis are eligible for the study.
C. Patients who are willing and are able to comply with the study protocol, including
taking homoeopathic treatment, attending follow-up assessments |
|
| ExclusionCriteria |
| Details |
A. Patients developing severe complications of tonsillitis such as:- Retropharyngeal
Abscess, Otitis Media (Middle Ear Infection), Post-Streptococcal Complications
(Acute Rheumatic Fever, PSGN etc.), Airway Obstruction, High Grade fever
(above 102 Degree F), Brodsky score 4th Grade Will be excluded.
B. Patients with severe systemic diseases with irreversible pathology that could
interfere with study’s primary outcome will be excluded.
C. Patients of Age under 5 years will be excluded from study.
D. Patients who are unable or unwilling to comply with the study protocol, such as
adhering to treatment regimen and attending follow-up visits will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on Brodsky Grading Scale & Numerical Pain Rating Scale |
At the baseline and at the end of each follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2025 |
| 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="6"
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
|
Prevelance of tonsillitis are more common in Preschoolers to middle-aged children are most frequently affected by tonsillitis. Nowadays, recurrent tonsillitis is one of the leading causes of kids missing school. It is Commonly seen at the age of 5years- 15years of age group. It is also seen in adults. Sore throat annual incidence is of 100 in 1000 with tonsillitis.In modern science specially in the cases of recurrent tonsillitis removal of the tonsils is the only option but with the help of homoeopathic medicine we can boost the immune system of the patients to fight against such recurrences and prevent them from undergoing such surgical procedures. Tonsillectomy mainly results in compromising the immune system of the body inviting other infections to affect the organism. This study will emphasis on incidence, classification, pathophysiology, clinical feature and management of tonsillitis with discussion of Homoeopathic medicines indicated in this clinical condition using BBCR. Homoeopathic literature acknowledge many medicines for the tonsillitis of which a simillimum can help a patient for keeping the disease far away for long period and offer a gentle and safe relief. |