| CTRI Number |
CTRI/2025/06/089613 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
How well homoeopathic medicines work for urinary infection in patients using a catheter by checking urine tests |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic medicines for urinary tract infection in catheterized patients by assessing urine analysis and culture - A quasi experimental study |
| 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 Binisha PT |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College Karaparamba Kozhikode |
| Address |
Department of practice of medicine
Government Homoeopathic Medical College Karaparamba
Kozhikode
Kerala
India
Kozhikode
KERALA
673010
India |
| Phone |
9061868698 |
| Fax |
|
| Email |
binishapt7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lizmy Jose |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Karaparamba Kozhikode |
| Address |
Department of practice of medicine
Government Homoeopathic Medical College Karaparamba
Kozhikode
Kerala
India
Kozhikode
KERALA
673010
India |
| Phone |
9447551747 |
| Fax |
|
| Email |
lizmyajith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binisha PT |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College Karaparamba Kozhikode |
| Address |
Department of practice of medicine
Government Homoeopathic Medical College Karaparamba
Kozhikode
Kerala
India
Kozhikode
KERALA
673010
India |
| Phone |
09061868698 |
| Fax |
|
| Email |
binishapt7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College
Kozhikode
Kerala
673010
India |
|
|
Primary Sponsor
|
| Name |
Dr Binisha PT |
| Address |
Post Graduate Scholar
Department of Practice of Medicine
Government Homoeopathic Medical College Karaparamba
Kozhikode
Kerala
673010
India |
| 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 Binisha PT |
Government Homoeopathic Medical College |
Department of Practice of Medicine
Hospital IP and OP
Room Number 3
Kozhikode
KERALA |
9061868698
binishapt7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College kozhikode Kerala |
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 |
Homoeopathic medicines |
Homoeopathic medicines for urinary tract infection selected based on Homoeopathic principles of similarity and minimum dose then administered orally for 2 weeks and the outcome was assessed by urine analysis and culture. The total study duration is for 1 year |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients who are on indwelling (foleys) catheterization of more than 2 days
admitted in in patient department and consult in out patient department
2.Patients with pus cells more than 5 HPF
3.Symptomatic patients with microorganisms more than 1000 CFU per ml
4.Asymptomatic patients with microorganisms more than 100000 CFU per ml
5.Patients not receiving conventional antibiotic treatment for last 1 week |
|
| ExclusionCriteria |
| Details |
1.patients infected with vaginitis
2.Patient who need emergency management like sepsis, endotoxic shock, crystalisation
in catheter, anuria
3.Gross structural and developmental abnormalities of urinary system
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in urine analysis (Pus cells, Bacteria)
2. Changes in urine culture
|
outcome assessed after 2 weeks of prescribing homoeopathic medicines according to principles of homoeopathy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/07/2025 |
| 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
|
A prospective clinical study will be conducted in patients attending the inpatient and outpatient sections of the Government Homoeopathic Medical College, Kozhikode. The period of study will be minimum of 1 year from date of onset of research. A minimum of 23 cases of UTI in catheterized patients satisfying the inclusion and
exclusion criteria will be taken up for the study. Consent is obtained after explaining the study in detail to the individual. urine analysis and culture will done in urinary tract infection suspected patients. All cases will be treated according to the principles of Homoeopathy. Each case will be reviewed at 2 weeks. Outcome of the treatment will be assessed by changes in urine analysis and culture. Final evaluation of data will be done by means of an appropriate statistical method. |