| CTRI Number |
CTRI/2025/08/093782 [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 |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to test if Santoninum 30C helps treat worm infections in children, using a dummy treatment for comparison |
|
Scientific Title of Study
|
A RANDOMIZED SINGLE BLIND, PLACEBO CONTROLLED TRIAL TO ASSESS THE EFFECTIVENESS OF SANTONINUM 30C IN CASES OF WORM INFESTATION 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 |
Mandeep Mahawar |
| Designation |
Post Graduate Resident |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
Department of Paediatrics Swasthya Kalyan Homoeopathic College and Research Cenrte
Department of Paediatrics Swasthya Kalyan Homeopathic and Research Centre
Jaipur
RAJASTHAN
302022
India |
| Phone |
07568927026 |
| Fax |
|
| Email |
2015mandeepmahawar@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 reserach centre jaipur
Jaipur
RAJASTHAN
302019
India |
| Phone |
07976638807 |
| Fax |
|
| Email |
Shobhateterwal@gmail.com |
|
Details of Contact Person
Public 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 reserach centre jaipur
RAJASTHAN
302019
India |
| Phone |
07976638807 |
| Fax |
|
| Email |
Shobhateterwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic College and Research Cenrte 10 A Institutional Area Tonk road Sitapura Jaipur |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homeopathic and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic College and Research Cenrte 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 |
| Mandeep Mahawar |
Swasthya Kalyan Homoeopathic College and Research Cenrte |
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 |
07568927026
2015mandeepmahawar@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: B839||Helminthiasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
SANTONINUM 30C |
Group A-
MEDICINE - SANTONINUM will be prescribed.
POTENCY – 30 C is being fixed
Dosage: Dosage as per susceptibility of the patient using 6 medicated globules per dose (No. 30 Size) Manufacturer- Medicine will be obtained from a GMP certified company.
Route of administration- Oral.
GROUP B
MEDICINE – PLACEBO will be prescribed
POTENCY – 30C is being fixed. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patient coming from other mode of treatment with no relief. |
|
| ExclusionCriteria |
| Details |
1. Cases which require emergency treatment.
2. Above 18 years
3. Cases which need surgical intervention.
4. Immuno compromised patient such as suffering from HIV, Hepatitis B C etc.
5. Cases with multi systemic illness and cases with advance pathology will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The homoeopathic management with santoninum 30c will be proven beneficial in the treatment of Worm infestation in paediatric age group. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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. The outcome of the study is that the homoeopathic management with santoninum 30c will be proven beneficial in the treatment of Worm infestation in paediatric age group. Primary objective is to assess the effectiveness of santoninum 30c in worm infestation among paediatric age group. Secondary objective is to observe the age incidence of worm infestation in paediatric age-group. |