| CTRI Number |
CTRI/2022/01/039077 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
15/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trail To Study The Effectiveness Of Homoeopathic Medicine In Treatment of Lower Urinary Tract Infection By Using Synthesis Repertory |
|
Scientific Title of Study
|
To Study The Effectiveness Of Homoepathic Medicine In The Treatment Of Lower Urinary Tract Infection In Age Group Between 18 years to 45 years By Using Synthesis Repertory |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Longjam Sunderlal Singh |
| Designation |
Doctor, P.G Scholar |
| Affiliation |
B.V.D.U.Homoepathic Medical College and Hospital,Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College,Department of Post Graduate and Research centre, Pune-Bangalore Highway , Pune - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8105141435 |
| Fax |
|
| Email |
Sunderfernandez210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra E Shinde |
| Designation |
Associate Professor |
| Affiliation |
B.V.D.U.Homoepathic Medical College and Hospital,Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College,Department of Post Graduate and Research centre, Pune-Bangalore Highway , Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9637206722 |
| Fax |
|
| Email |
rajendra.shinde@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Longjam Sunderlal Singh |
| Designation |
Doctor, P.G Scholar |
| Affiliation |
B.V.D.U.Homoepathic Medical College and Hospital,Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College,Department of Post Graduate and Research centre, Pune-Bangalore Highway , Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8105141435 |
| Fax |
|
| Email |
Sunderfernandez210@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.V.D.U.Homoepathic Medical College and Hospital,Department of Post Graduate and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Longjam Sunderlal Singh |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College,Department of Post Graduate and Research centre, Pune-Bangalore Highway , Pune - 411043 |
| 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 Longjam Sunderlal Singh |
B.V.D.U.Homoepathic Medical College and Hospital,Department of Post Graduate and Research Centre |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College,Department of Post Graduate and Research centre, Pune-Bangalore Highway , Pune - 411043
Pune
MAHARASHTRA |
08105141435
Sunderfernandez210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B.V.D.U.H.M.C 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 Medicines obtained after Repertorization from Synthesis Repertory |
Homoeopathic Medicines obtained after Repertorization from Synthesis Repertory. Potency 30C,200C,1M.
Form: Globules,Powder or Liquid
Route of Administration: Oral Route
Duration of Treatment : 3 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with lower urinary tract infections will be included irrespective of their occupation and socio economic status.
2.Both sexes male and female will be included .
3.Patient of 18 to 45 years age group.
4.Patient who are willing to give their consent.
|
|
| ExclusionCriteria |
| Details |
1.Complicated Urinary Tract Infection will be excluded.
2.Patients who needed emergency medical intervention will be excluded..
3.Patient associated with any other chronic and systemic disease on active treatment like chronic kidney disease.
4.Patient with STDs like Syphilis, Gonorrhoea etc..
5. Pregnant women will be excluded.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To study the utility of Synthesis Repertory in treatment of Lower Urinary Tract Infection.
2)To check the effectiveness of homoeopathic medicine in case of Lower Urinary Tract Infection . |
1)Improvement in clinical findings and urine routine within 7days and again after every 15 days till the symptoms resolve.
2) Quality of life Questionnaire Assessment will be done in every follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical findings and urine routine within 7 days and after every 15 days for period of 3 months |
Assessment on day 1,day 5 and then at a gap of 15days till the symptoms resolve. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
05/01/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Board Spectrum of antibiotics are used to treat Lower Urinary Tract Infection and Its led to bacterial resistance and cause secondary infection etc . The treatment include management of pain by administration of antibiotics,fluid supplements etc .If it fails IV antibiotics are given .The medicines given for urinary tract infection are Ciprofloxacin, Levofloxacin,Nitrofurantoin,Ceftriaxone in itself caused many side effects and can be harmful for patients. The more effective mode of treatment are needed to cure Lower Urinary Tract Infection and Homoeopathy can act as a safe and effective way to cure. So, through this way,we can observed the effectiveness of homoeopathic medicines in patients of Lower Urinary Tract Infection without any side effects . |