| CTRI Number |
CTRI/2024/04/066434 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicine in Recurrent Urinary tract infections in Menopausal womens |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Antimiasmatic Medicines in
Recurrent Urinary Tract Infections in Menopausal Womens A Prospective 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 Bhavana Chaudhary |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute Mehsana Gujarat |
| Address |
Department of Gynecologist and Obstetric
Room No 8
Ground Floor
Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7863079066 |
| Fax |
|
| Email |
bhavanachaudhary2912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Raval |
| Designation |
Associate Professor |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute Mehsana Gujarat |
| Address |
Department of Organon Of Medicine and Homoeopathic Philosophy
Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9979133069 |
| Fax |
|
| Email |
ravalmayank3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BHAVANA CHAUDHARY |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute Mehsana Gujarat |
| Address |
Department of Gynecologist and Obstetric
Room No 8
Ground Floor
Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7863079066 |
| Fax |
|
| Email |
bhavanachaudhary2912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District Session Court Mehsana Gujarat 384001 |
|
|
Primary Sponsor
|
| Name |
DR BHAVANA CHAUDHARY |
| Address |
Department of Gynecologist and Obstetrics
Room No 8
Ground Floor
Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana Gujarat 384001 |
| 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 Bhavana Chaudhary |
Smt A J Savla Homoeopathic Medical College and Research Institute |
Department of Gynecologist and obstetrics
Room No 8
Ground floor
Pushpanjali Building Near District Session Court Mehsana Gujarat 384001
Mahesana
GUJARAT |
7863079066
bhavanachaudhary2912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical College Institutional Ethical 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 |
Homoeopathic Antimiasmatic Medicine |
Doses as per Need of cases
Frequency as per the need of cases at every 7 to 15 days upto 8 month of duration
Route of Administration Oral
Duration of therapy upto for 8th months as per the need of case
Potency Various such as Decimal Centesimal 50Millesimal etc
Medicines will be dispensed as per potency
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1 Cases with history of urinary tract infections 2-3 episodes within the 6 month will be
selected irrespective of socio Economic conditions
2 Samples are selected only by symptomatic verification of Recurrent UTIs according to ICD 10 Criteria Code Z87 440
|
|
| ExclusionCriteria |
| Details |
1 Patients suffering from other severe Renal diseases such as Severe Pyelonephritis Nephritis
syndrome Chronic Renal failure Renal Stone
2 Patients under any other alternative treatment and Homoeopathic treatment
3 Patients suffering from other Complicated Systemic Disease such as Diabetes mellitus
Hypertension Hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Significant Improvement No Recurrencey Total control of the symptoms
2 Improvement Recurrencey Once in 6 month Symptomatic relief
3 Status quo Recurrencey No any Improvements in signs and symptoms
4 Left the Treatment Worsening of Complaints |
At baseline and after the treatment that is at the end of 8 month duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/05/2024 |
| Date of Study Completion (India) |
05/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
This study is a Prospective Study pre test-post test one group Experimental study to assess the efficacy of Homoeopathic Antimiasmatic Medicine for 8 months in 40 participants with Recurrent UTI in Menopausal Womens that will be conducted as per inclusion and exclusion criteria from outpatient department and the outcomes measures will assess the reduction in frequency and urinary symptoms of the participants follow up as per need of case at every 7 or 15 days up to for 8th months of duration |