| CTRI Number |
CTRI/2024/02/063204 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Role os Homoeopathic Medicines in the Management of Urinary Tract Infection |
|
Scientific Title of Study
|
A Clinical Study on Culture Positive Urinary Tract Infection In Females and its Homoeopathic Management |
| 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 Shilpa Bhaskar |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road NH47 Chinnaseeragapadi Salem 636308
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road NH47 Chinnaseeragapadi Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9900710103 |
| Fax |
|
| Email |
shilu0906@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Nirubanraj |
| Designation |
Associate Proffessor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road NH47 Chinnaseeragapadi Salem 636308
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road NH47 Chinnaseeragapadi Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9894821412 |
| Fax |
|
| Email |
nirubanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Nirubanraj |
| Designation |
Associate Proffessor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road NH47 Chinnaseeragapadi Salem 636308
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road NH47 Chinnaseeragapadi Salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9894821412 |
| Fax |
|
| Email |
nirubanraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital Sankari Main Road Chinnaseeragapadi Salem Tamilnadu 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Sankari Main Road NH47 Chinnaseeragapadi Salem 636308 |
| Type of Sponsor |
Private 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 Shilpa Bhaskar |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room NO- 3-PG Department of Homoeopathic Materia Medica OPD Medical Unit II, Ground Floor,Hospital Block,VMHMCH,SAankari Main Road NH47,Chinnaseeragapadi Salem 636308
Salem
TAMIL NADU |
9900710103
shilu0906@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
The sample of only females
Diagnosed Case of Urinary Tract infections
Age group between 16-60 years |
|
| ExclusionCriteria |
| Details |
Patients with diabetes mellitis, immunocompromised disease conditions.disease involving pathogens. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic improvement using Homoeopathic medicines in cases of urinary tract infection |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
23/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Urinary tract infections are common infections that happens when bacteria often from skin or rectum,enter urethra and infect the urinary tract. The infections can affect several parts like urethra ,kidney, ureters, bladder.It may manifest as acute or recurrent uncomplicated cystitis,acute uncomplicated pyelonephritis or asymptomatic bacteriuria . |