| CTRI Number |
CTRI/2025/09/094694 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing Streptococcinum to Reduce Repeated Tonsillitis in Children Aged 3–15 Years: A Randomized Study |
|
Scientific Title of Study
|
To Ascertain The Efficacy Of Streptococcinum As An
Intercurrent Remedy In Reducing The Recurrency Of
Tonsillitis In Paediatric Age Group(3–15 Years): A
Parallel Arm, Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika |
| Designation |
PG Scholar |
| Affiliation |
Dr Madan Pratap Khunteta Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Paediatric Opd Room No. 9 Dr Madan Pratap Khunteta Homoeopathic Medical College
Hospital And Research Centre Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
6239859337 |
| Fax |
|
| Email |
2108vanshika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanshika |
| Designation |
PG Scholar |
| Affiliation |
Dr Madan Pratap Khunteta Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Paediatric Opd Room No. 9 Dr Madan Pratap Khunteta Homoeopathic Medical College
Hospital And Research Centre Jaipur
RAJASTHAN
302029
India |
| Phone |
6239859337 |
| Fax |
|
| Email |
2108vanshika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vanshika |
| Designation |
PG Scholar |
| Affiliation |
Dr Madan Pratap Khunteta Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Paediatric Opd Room No. 9 Dr Madan Pratap Khunteta Homoeopathic Medical College
Hospital And Research Centre Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
6239859337 |
| Fax |
|
| Email |
2108vanshika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Madan Pratap Khunteta Homoeopathic Medical College And Research Centre Jaipur India Pincode 302029 |
|
|
Primary Sponsor
|
| Name |
Dr Madan Pratap Khunteta Homoeopathic Medical College Hospital And Research Centre |
| Address |
Dr Madan Pratap Khunteta Homoeopathic Medical College
Hospital And Research Centre Jaipur Plot 10 11 12 Saipura Sanganer Jaipur 302029 |
| Type of Sponsor |
Private 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 Prasoon Choudhary |
Dr Girendra Pal Homeopathic Medical College, Hospital and Research Centre |
Department Of Paediatrics OPD Room No. 9 Dr Girendra Pal Homeopathic Medical College Hospital and Research
centre Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN |
9414718100
drprasoonchoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Homoeopathic University Ethics 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 |
| Comparator Agent |
1. Belladonna
2. Hepar sulphur
3. Baryta carbonica
4. Mercurius solubilis
5. Lycopodium
6. Phytolacca
7. Baryta muriatica |
These individualised homoeopathic medicines are administered in 30C or 200C daily three times a day for 1-2 week |
| Intervention |
Streptococcinum |
Streptococcinum is administered in 200C or 1M potency
weekly or fortnightly |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 3–15 years
2. equal or more than 3 episodes in 6 months or equalor more than 5 in a year
3. Informed written consent and assent from guardians/parents/child
4. Each episode of tonsillitis must include one or more of the following, in addition to a sore throat:
a. Temperature of 38.3°C (100.9°F) or higher.
b. Tender cervical adenopathy (swollen lymph nodes in the neck).
c. Tonsillar exudates (pus on the tonsils).
d. A positive culture for Group A beta-hemolytic streptococcus (the bacteria that causes strep throat
5. Cases of recurrent tonsilitis ICD 11(CA0F.Y) and ICD 10(J35.0) |
|
| ExclusionCriteria |
| Details |
1. Acute tonsillitis at time of enrolment
2. Prior tonsillectomy or planned surgery
3. Systemic chronic illness or immune disorders
4. Current use of other complementary therapies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The study is expected to show the effectiveness of Streptococcinum as an
intercurrent remedy in reducing the cases of tonsillitis in children ages 3-15
years.7,9,1
2. The study is expected to show a comparison of the two groups, pointing
out the difference in efficacy in the two groups and medicines used.
3. The study will help to find the average duration of medication required in
cases of recurrent tonsillitis in ages 3-15years |
Evaluation of recurrent tonsillitis reported by the no. of episodes and the
intensity.
• Evaluation in every 2 weeks
• Study end point: 6 months after the last registered case |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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
|
his research is a randomized controlled trial conducted in children aged 3 to 15 years with recurrent tonsillitis to ascertain the role of Streptococcinum as an intercurrent remedy along with individualized homoeopathic treatment in minimizing recurrence and improving overall outcomes in terms of frequency intensity and duration of episodes |