| CTRI Number |
CTRI/2025/02/080607 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicines for treating bacterial tonsilitis |
|
Scientific Title of Study
|
Role of Individualized Homoeopathic Medicines
In Post-Streptococcal Sore Throat With Elevated Anti-Streptolysin
O Antibody in Paediatric Age Group: A Single-Arm Pre-Post
Interventional Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1318-8262 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gargi Mandal |
| Designation |
Post Graduate Trainee, |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Pediatric Department, room No. 32, GE Block, sector 3, Bidhannagar, kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9775171322 |
| Fax |
|
| Email |
drgargimandal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shishir Kumar Singh |
| Designation |
Associate Professor and head department of pediatrics |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Pediatric department OPD NO 32 GE Block, sector 3, Bidhannagar, kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7890321978 |
| Fax |
|
| Email |
drshishirsinghmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shishir Kumar Singh |
| Designation |
Associate Professor and head department of pediatrics |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Pediatric Department, room No. 32, GE Block, sector 3, Bidhannagar, kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7890321978 |
| Fax |
|
| Email |
drshishirsinghmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Salt Lake Sector 3, Kolkata 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Salt Lake Sector 3, Kolkata 700106 |
| Type of Sponsor |
Government medical college |
|
|
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 Gargi Mandal |
National Institute of Homoeopathy |
Pediatric department, OPD NO. 32 Block GE, Salt Lake Sector 3, Kolkata 700106
Kolkata
WEST BENGAL |
9775171322
drgargimandal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A409||Streptococcal sepsis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicines. |
Intervention is planned as administering indicated homoeopathic medicines in centesimal
potencies (CH). Each dose will consist of 4 cane sugar globules no. 20 moistened with the
indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty
stomach; dosage and repetition depending upon the individual requirement of the cases. Patients
will be advised to refrain from handling the globules or from eating, drinking, smoking or
brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules
rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional
features, miasmatic expressions, repertorization using ‘HOMPATH’, ‘RADAR’ and ‘ISIS’
software when required with due consultation of Materia Medica and due consensus among
three homoeopaths. All the medicines and sundry items will be procured from a Good
Manufacturing Practice (GMP) certified firm. Duration of therapy: 3 months
Concomitant care: Along with medicines, all the patients will receive advice on gargling with
luke-warm saline water. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children suffering from sore throat of recent onset (more than 3 days), representing with
clinical features of acute tonsillitis and bacterial aetiology confirmed by throat swab
culture, and high ASO titre.
2. Participants of all sex.
3. Age between 5 and 15 years.
4. Literate patient’s parents; ability to read and write in Bengali and/or English and /or
Hindi. Illiterate participants will be interviewed by the investigators maintaining
adequate privacy to fill up the scale or questionnaires.
5. The parents providing written informed consent voluntarily and the children providing
with informed assent. |
|
| ExclusionCriteria |
| Details |
1. Causes other than Bacterial.
2. Presence of uncontrolled co-morbidities.
3. Self-reported immune-compromised state.
4. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation,
terminally ill or critically ill patients, mentally incompetent people.
5. Simultaneous participation in any other clinical trials. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To detect the differences in serum anti streptolysin o antibody level in the paediatric age group
with post-streptococcal sore throat after second and third months of treatment with
individualised homoeopathic medicine. |
Day 0, month 2 and month 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale [ VASs] of sore throat pain
model (STPM), namely pain VAS (STPIS), difficulty in swallowing VAS (DSS), and
swollen throat VAS (swoTS) |
day 0, month 1, month 2, month 3 |
Modified Naranjo Criteria
(MONARCH) |
Month 3 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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
|
This study is intended to examine common pediatric conditions in clinical settings; despite this, there is a lack of evidence. Tonsillitis detected from bacterial origin confirmed by throat swab culture. The primary objective of this study is to evaluate the changes in ASO titre level at day 0 and month 2 and in month 3. The secondary objective of this study is to look after the sore throat pain model VAS level at day 0, and every month up to 3 months. Besides that, there is also look after the MONARCH at three months for look after the causal attribution of treatment. This is an open-lebel single-arm trial. Here intervention is used as individualized homoeopathic medicine according to the case symptoms similarity with concomitant care of lukewarm saline water gurgle. Dose and repetition guided by symptoms similarity and according to hommeopathic principals. The study contains only a sample size of 30 and the duration of therapy for three months. |