| CTRI Number |
CTRI/2025/03/083081 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How likely symprtoms of a Homoeopathic medicine helps in treating Urinary Tract Infection. |
|
Scientific Title of Study
|
Prevalence and Likelihood Ratio of symptoms in patients treated for Urinary Tract Infections with Good Therapeutic Response to Individualized Homoeopathic Medicine: A Prognostic Factor Research |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaushal Kumar Savera |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Room No. 118, National Homoeopathy Research Institute in Mental Health
S Puram PO
Kottayam
KERALA
686532
India |
| Phone |
8820804995 |
| Fax |
|
| Email |
drkksavera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kaushal Kumar Savera |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Room No. 118, National Homoeopathy Research Institute in Mental Health
S Puram PO
Kottayam
KERALA
686532
India |
| Phone |
8820804995 |
| Fax |
|
| Email |
drkksavera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaushal Kumar Savera |
| Designation |
Research Officer (Homoeopathy) |
| Affiliation |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Room No. 118, National Homoeopathy Research Institute in Mental Health
S Puram PO
Kottayam
KERALA
686532
India |
| Phone |
8820804995 |
| Fax |
|
| Email |
drkksavera@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, S Puram PO, Kottayam, Kerala 686532 |
|
|
Primary Sponsor
|
| Name |
Kaushal Kumar Savera |
| Address |
Room No. 118, National Homoeopathy Research Institute in Mental Health, S Puram PO, Kottayam, Kerala 686532 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kaushal Kumar Savera |
National Homoeopathy Research Institute in Mental Health |
Room No. 118, S Puram PO, Kottayam, Kerala 686532
Kottayam
KERALA |
8820804995
drkksavera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, NHRIMH, Kottayam |
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 medicine |
Source of medicine:
The Individualized homoeopathic medicines used in the study shall be from Good Manufacturing Practices licensed company.
Selection of medicine:
A detailed case-taking will be done using pre-defined Case Recording Form (CRF). Totality of the symptoms will be erected based on presenting symptoms after evaluation of all symptoms obtained in case taking. Repertorization will be done using available software. Based on the repertorial result and references to Homoeopathic Materia Medica final selection of medicines will be done.
The CRF will include the analysis, evaluation of symptoms and repertorial chart. Proper justification for selection of remedy and potency shall be written in the case record. Prescribing symptoms of UTI for which medicine given will be duly noted in CRF. The single selected individualized homoeopathic medicine will be prescribed.
Selection of Potency, mode of administration and repetition of medicine:
Individualized Homoeopathic Medicine shall be prescribed in centesimal potencies as per the prescribing totality and the susceptibility of the case according to the principles of posology. Oral administration of the medicines will be done in all cases. Repetition of medicine will be as per discretion of investigator based on patient’s conditions and principles of posology.
Dose and dispensing of medicines:
The pharmacist of this institute will dispense the medicines as per the direction given in prescription. Each dose of Homoeopathic medicine shall consist of 1 teaspoonful (5 gram) of sugar of milk saturated with the specified dilution. All the patients will be also given sufficient number of blank tablets used as placebo during treatment period.
|
| Comparator Agent |
NIL |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of all gender and all age group.
2. Diagnosed with UTI by urine culture.
3. Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient under any other medication.
2. Patients with major systemic diseases.
3. Pregnant and lactating women due to ethical consideration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| General improvements of the patients suffering from Urinary Tract Infection. |
Baseline and thereafter every 4 week, upto 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in the signs & symptoms in the patients of UTI. |
Baseline, thereafter every 4 weeks, upto 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/04/2025 |
| 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="7"
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
|
| Study Title | Prevalence and Likelihood Ratio of symptoms in patients treated for Urinary Tract Infections with Good Therapeutic Response to Individualized Homoeopathic Medicine: A Prognostic Factor Research | | Study design | An Open Label, Non-Randomised, prospective, patient outcome, Longitudinal Study. | | Study duration | 1year and 7 months (1 year for enrolment + 6 months for follow up + 1 month for data compilation) | | Study centre(s) | National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala, India. | | Objective (s) | Primary: To identify clinically useful homeopathic remedies and their characteristic indications using the prognostic factor research model for UTI. Secondary: To compare the gradation of medicines under a rubric (symptom) in Kent repertory. | | Sample Size | Calculation of sample size not required. Minimum 20 cases of each medicine enrolled during one year will be analysed for calculating LR and prevalence. | | Inclusion and Exclusion criteria | Inclusion Criteria: · Subjects of all gender and all age group. · Diagnosed with UTI by urine culture. · Willing to participate in the study. Exclusion criteria: · Patient under any other medication. · Patients with major systemic diseases. · Pregnant and lactating women due to ethical consideration. | | Study product, Dose, regimen | Individualized Homoeopathic medicine will be prescribed to the patients suffering from UTI as per the principles of Homoeopathy. | | Statistical methodology | Based on the Bayes’ theorem, posterior odds of the symptoms improved by the medicine will be calculated. | | PhD Scholar Name | Dr. Kaushal Kumar Savera Research Officer/Scientist 2, NHRIMH, Kottayam Provisional Registration Number: PHD221673I | | Supervising Guide | Dr. Sitharthan R, Principal & HOD, Dept. of Practice of Medicine NHRIMH, Kottayam 686532 | | Co-Guide | Dr. Rejitha K Nair, Professor Dept. of Case Taking and Repertory, Govt. Homeopathic Medical College, Thiruvananthapuram | | Hypothesis | As it is not an experimental study, hypothesis was not drawn. | |