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CTRI Number  CTRI/2024/05/068121 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Individualised Homoeopathic medicine in case of Painful bladder syndrome. 
Scientific Title of Study   An Observational study of homoeopathy in painful bladder syndrome.  
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 Vivek Kumar Shail 
Designation  Assistant Professor Practice of Medicine 
Affiliation   
Address  Academic Block Room no 3 RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Ramdyalunagar Muzaffarpur Bihar 842002 India

Muzaffarpur
BIHAR
842002
India 
Phone  8298994658  
Fax    
Email  drviknih@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kumar Shail 
Designation  Assistant Professor Practice of Medicine 
Affiliation   
Address  Academic Block Room no 3 RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Ramdyalunagar Muzaffarpur Bihar 842002 India

Muzaffarpur
BIHAR
842002
India 
Phone  8298994658  
Fax    
Email  drviknih@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Kumar Shail 
Designation  Assistant Professor Practice of Medicine 
Affiliation   
Address  Academic Block Room no 3 RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Ramdyalunagar Muzaffarpur BIHAR 842002 India

Muzaffarpur
BIHAR
842002
India 
Phone  8298994658  
Fax    
Email  drviknih@gmail.com  
 
Source of Monetary or Material Support  
RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Ramdyalunagar Muzaffarpur Bihar 842002 India  
 
Primary Sponsor  
Name  RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Ramdyalunagar Bihar India  
Address  RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Ramdyalunagar Muzaffarpur Bihar 842002 India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr PRINCE KUMAR  RBTS Govt Homoeopathic Medical College and Hospital  Out patient department 1 3 & 5 Muzaffarpur BIHAR
Muzaffarpur
BIHAR 		 8969563109

princekumarsahay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N329||Bladder disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic medicine  Intervention is planned as administering Constitutional medicine in empirical dosage from inclusion in the study until the end of the follow-up with a maximum of three months duration for each patient. Homeopathic medicines in centesimal potencies in required doses shall be prescribed to be taken orally.  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patient diagnose with Painful Bladder Syndrome according to established clinical Criteria.
Both sexes
Willingness to participate in the study and provide informed consent.  
 
ExclusionCriteria 
Details  Patient with a history of severe systemic disease affecting the Bladder( Cancer, severe infection, etc)
Patients unwilling or unable to comply with the study requirement
substance abuse and dependence
others any co-morbidity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in pain scores measured using a validated pain scale (e.g., Visual Analog Scale)
at regular intervals. Assessing pain (VAS). The Visual Analogue Scale (VAS) measures pain
intensity. The VAS consists of a 10cm line, with two end points representing 0 (‘no pain’) and
10 (‘pain as bad as it could possibly be’) 		 2week, more or less 3days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in urinary frequency and urgency.
Quality of life assessed using a standardized questionnaire (e.g., Interstitial Cystitis
Symptom and Problem Indices).
Adverse events related to homeopathic treatment. 		 3 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 4 
Date of First Enrollment (India)   11/06/2024 
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 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   The purpose of this study is to investigate the efficacy of individualized homeopathic medicine in the management of Painful Bladder Syndrome (PBS). This observational study aims to assess the impact of homeopathic remedies on pain levels, urinary frequency, and overall quality of life in patients suffering from PBS. It can be a valuable endeavour to explore alternative approaches to managing this condition.  
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