| CTRI Number |
CTRI/2025/04/084589 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
AN OPEN LABEL SINGLE ARM CLINICAL TRIAL TO ASSESS THE EFFECTS OF SARSAPARILLA 3X IN URINARY TRACT INFECTION IN ADULTS OF 18-45years |
|
Scientific Title of Study
|
AN OPEN LABEL STUDY TO ASSESS THE EFFECTIVENESS OF SARSAPARILLA OFFICINALIS 3X IN URINARY TRACT INFECTION BY ESTIMATING PUS CELLS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Shee |
| Designation |
Student |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Metropolitan Homoeopathic Medical College and Hospital, Organon
of Medicine Department, O.P.D -2; Ramchandrapur sodepur
Ramchandrapur, Sodepur Kolkata 700110
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
6290119594 |
| Fax |
|
| Email |
shreyashee00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Doctor Ehtesham Khan |
| Designation |
Associate Professor of Organon of Medicine Department |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Metropolitan Homoeopathic Medical College and Hospital,
Department of Organon of Medicine; O.P.D- 2; Ramchandrapur
sodepur Ramchandrapur, Sodepur Kolkata 700110
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
8100099839 |
| Fax |
|
| Email |
ehtesham.khan.nih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Doctor Chandranath Das |
| Designation |
Principal - Superintendent |
| Affiliation |
Metropolitan Homoeopathic Medical College and Hospital |
| Address |
Metropolitan Homoeopathic Medical College and Hospital, Pathology Department, O.P.D -1; Ramchandrapur sodepur
Ramchandrapur, Sodepur Kolkata 700110
North Twentyfour Parganas
WEST BENGAL
700110
India |
| Phone |
03325955326 |
| Fax |
|
| Email |
mhmch1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metropolitan Homoeopathic Medical College and Hospital, Ramchandrapur Kolkata 700110;
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Metropolitan Homoepathic Medical College and Hospital |
| Address |
Ramchandrapur, Sodepur Kolkata 700110 |
| 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 |
| Doctor Chandranath Das |
Metropolitan Homoeopathic Medical College and Hospital |
Organon of Medicine
Department, O.P.D-2,
Ramchandrapur
Sodepur Kolkata
700110
North Twentyfour Parganas
WEST BENGAL |
03325955326
mhmch1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Metropolitan Homoeopathic Medical College and Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N300||Acute cystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Sarsaparilla Officinalis 3X |
Sarsaparilla Officinalis 3X potency twice a day, repetition and dose will be based on
questionnaire scoring |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of urinary tract infection and/or with clinical features of UTI of age group 18- 45years,in females irrespective of their socio-economic status.
2. Patients having pus cells in urine greater than 10/HPF.
3. Subjects agree to comply with the protocol. |
|
| ExclusionCriteria |
| Details |
1. Patients associated with conditions like myocardial infarction, renal failure, hepatic failure, malignancies and metabolic disorders like diabetes mellitus with clinical evidences and complicated cases of UTI such as pyelonephritis, urethral stricture, sepsis with clinical evidences.
2. Patients are unconscious, ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people, unstable mental or psychiatric illness.
3. Already taking treatment for any other chronic diseases.
4. Patient who has been dealing with urinary symptoms with several modern medication.
5. Pregnant and lactating mothers.
6. Catheter induced UTI.
7. Self-reported immune-compromised state. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre post changes in pus cell count in routine examination of urine |
Pre post changes in pus cell count in routine examination of urine, 2 weeks from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| UTI Symptom Assessment questionnaire, TLC in CBC report |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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="0"
Months="6"
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 an open label, single arm study to assess the effectiveness of Homoeopathic medicine Sarsaparilla 3x among 53 patients by estimating pre-post changes in pus cells in Routine urine examination. Sarsaparilla 3x will be administered twice daily and the dose and repetition will be done based on UTISA scoring. Primary outcome includes pus cells estimation in routine urine examination at baseline, at 7th day and again at 14th day. For secondary outcome UTISA questionnaire scoring is to be assessed at baseline , 7th day and 14th whereas Total Leucocyte Count (TLC) only at baseline and 14th day. |