| CTRI Number |
CTRI/2025/08/093725 [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
|
Testing Individualized Homoeopathic medicines for treating urinary tract infections in children |
|
Scientific Title of Study
|
A randomised control trial study to ascertain the role of individualized homeopathic medicines in the management of acute lower urinary tract infection in paediatric age group(2-15 years)
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Kumar Mehta |
| Designation |
Post Graduate Resident |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
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
302022
India |
| Phone |
08107794587 |
| Fax |
|
| Email |
mehtadrsunil2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjli Agarwal |
| Designation |
Associate Professor |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
B-3 sundarnagar,new sanganer
road,opposite patel marg,
Mansarovar jaipur
Swasthya Kalyan Homeopathic and Research Centre 10 A Institutional Area Tonk road Sitapura Jaipur
Jaipur
RAJASTHAN
302020
India |
| Phone |
7023651862 |
| Fax |
|
| Email |
pranjliagarwal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjli Agarwal |
| Designation |
Associate Professor |
| Affiliation |
Swasthya kalyan Homeopathic College and Research Centre |
| Address |
B-3 sundarnagar,new sanganer
road,opposite patel marg,
Mansarovar jaipur
Swasthya Kalyan Homeopathic and Research Centre 10 A Institutional Area Tonk road Sitapura Jaipur
RAJASTHAN
302020
India |
| Phone |
7023651862 |
| Fax |
|
| Email |
pranjliagarwal25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic College and Research Cenrte 10 A Institutional Area Tonk road Sitapura,Jaipur 302022 Rajasthan |
|
|
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 302022 Rajasthan |
| 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 |
| Sunil Kumar Mehta |
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 |
08107794587
mehtadrsunil2017@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: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Group A- Individualised Homeopathic medicines will be prescribed.
Potency and dosage: Dosage as per susceptibility of the patient.
Manufacture- Medicine will be obtained from a GMP certified company.
Route of Administration- Oral
Group B - Placebo 30 will be prescribed.
Potency and dosage: Dosage as per susceptibility of the patient.
Manufacture- Medicine will be obtained from a GMP certified company.
Route of Administration- Oral
Co-Intervention:
1. Avoid processed food, fried food, hard, spicy, and acidic foods, and drinks.
2. Avoid smoking, alcohol consumption.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients coming from other modes of treatment with no symptom relief. |
|
| ExclusionCriteria |
| Details |
1. Children requiring emergency treatment or surgical intervention.
2. Patients above 15 years of age.
3. Immunocompromised children (e.g., HIV, Hepatitis B C).
4. Cases with multi-systemic illness or advanced pathological conditions. |
|
|
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 will be proven beneficial in the treatment of acute lower
urinary tract infection in Paediatric age group. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will help to develop and implement in Homeopathic management of acute lower
urinary tract infection. |
12 months |
|
|
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 a randomised control trial study to ascertain the role of individualized homeopathic medicines in the management of acute lower urinary tract infection in paediatric age group (2-15 years). The study will be conducted at OPD/IPD of the Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur. The Homoeopathic management will be proven beneficial in the treatment of acute lower urinary tract infection in Paediatric age group. The study will help to develop and implement in Homeopathic management of acute lower urinary tract infection are the outcome of the study. The objective of the study are To ascertain the efficacy of individualized Homoeopathic medicine in cases of acute lower urinary tract infection of in Paediatrics age group. To observe the age incidence of acute lower urinary tract infection in Paediatrics age group. |