| CTRI Number |
CTRI/2025/03/082274 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in Lower Urinary Tract Infection |
|
Scientific Title of Study
|
A Clinical Study to Assess the Effectiveness of Individualised Homoeopathic Medicine in the Treatment of Lower Tract Infection |
| 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 Mohanraj M S |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and hospital |
| Address |
Department Of Practice of Medicine,Nehru Homoeopathic Medical College and Hospital,B block ,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
9087965036 |
| Fax |
|
| Email |
drmohanrajms05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Thakkar |
| Designation |
HOD (Practice of Medicine) |
| Affiliation |
Nehru Homoeopathic Medical College and hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical College and hospital, B block, Defence Colony, New Delhi
South
DELHI
110024
India |
| Phone |
8851006347 |
| Fax |
|
| Email |
rakeshthakkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohanraj M S |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and hospital |
| Address |
Department of Practice of Medicine, Nehru Homoeopathic Medical College and Hospital
South
DELHI
110024
India |
| Phone |
9087965036 |
| Fax |
|
| Email |
drmohanrajms05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical college and Hospital, B block, Defence Colony,New Delhi, Pincode 110024 |
|
|
Primary Sponsor
|
| Name |
NehruHomoeopathic Medical College and Hospital |
| Address |
B block,Defence Colony ,New Delhi ,110024 |
| 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 Mohanraj M S |
Nehru Homoeopathic Medical College and Hospital |
Room no 3(General opd),Ground floor,Nehru Homoeopathic Medical College and Hospital,B Block,Defence Colony,New Delhi
South
DELHI |
9087965036
drmohanrajms05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE-NHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N302||Other chronic cystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicines |
After screening and obtaining consent using specified selection (inclusion and exclusion) criteria, 30 eligible patients will be included in the trial. Following that patient will be planned to receive individualized homoeopathic remedy. Individualized dose will be selected on the judgement of susceptibility of the patients. Subsequent prescription will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. All medicines will be procured from good manufacturing practice(GMP) certified firm .Selection of potency, dosage and mode of administration will be based upon the severity of symptoms, susceptibility of the patient, miasmatic background. Mode of administration will be oral. Depending upon the severity of symptoms, reaction of patient and susceptibility of patient, repetition of remedy will be done. Follow up will depend upon the necessity and severity of the case. Preferably once every two to three weeks |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with more than 2 attacks of urinary tract infection with in last 6 months.
2. Age between 18-60 yrs old.
3. Cases belong to both sexes.
4. Those cases fulfill the diagnostic criteria. 5. All socio-economic groups |
|
| ExclusionCriteria |
| Details |
1. Persons with urinary tract anomalies and renal pathology.
2. Cases of urinary tract infections with neurogenic bladder and indwelling catheter.
3. Patients with immune suppressive treatment.
4. Pregnant and lactating women
5. Subject does not agree to give consent for participating in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing Improvement Using Symptom History Urine Analysis Score |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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
|
This is a Clinical Study to Assess the Effectiveness of Individualised Homoeopathic medicine in the Treatment of Lower Urinary Tract Infection. 30 Patients wil be Enrolled in the Study after getting consent from the patient. Study wil be of one year duration. Improvement in Symptoms are assessed by using Symptom History Urine Analysis Score .
Research question: Is there any difference in the symptoms and diagnostic parameters of lower urinary tract infection before and after treatment with individualized homoeopathic medicines? Hypothesis: Null hypothesis (H0): There will be no significant changes in the symptoms and diagnostic parameters after individualized homoeopathic treatment. Alternative hypothesis (HA): There will be significant changes in the symptoms and diagnostic parameters after individualized homoeopathic treatment.
AIM
To Assess The Effectiveness of Individualised Homoeopathic Medicine in Treatment of Lower Urinary Tract Infections.
OBJECTIVES
1. To Evaluate The Effectiveness of Individualised Homoeopathic Medicine in Improving Symptom History Urine Analysis Score in Lower Tract Infection 2. To Find out Most Frequently Indicated Medicines in Lower Urinary Tract infection |