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CTRI Number  CTRI/2024/06/069672 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Using homoeopathy to treat enlarged prostate  
Scientific Title of Study   A Clinical Study On The Effectiveness Of Anti- Miasmatic Medicines In The Management Of Benign Prostatic Hyperplasia  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhanalekshmi M S 
Designation  PG Scholar 
Affiliation  White Memorial Homoeo Medical College and Hospital  
Address  Department of Organon of Medicine and Homoeopathic Philosophy White Memorial Homoeo Medical College and Hospital Attoor Veeyanoor PO Tamilnadu

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9633736136  
Fax    
Email  dr.dhanalekshmi.m.s@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indu P 
Designation  Professor and HOD of Department of Organon of Medicine and Homoeopathic Philosophy  
Affiliation  White Memorial Homoeo Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy White Memorial Homoeo Medical College Attoor Veeyanoor PO Tamilnadu 629177

Kanniyakumari
TAMIL NADU
Veeyanoor
India 
Phone  9495704030  
Fax    
Email  indusujan9495@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dhanalekshmi M S 
Designation  PG Scholar 
Affiliation  White Memorial Homoeo Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy White Memorial Homoeo Medical College and Hospital Attoor Veeyanoor PO Tamilnadu

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9633736136  
Fax    
Email  dr.dhanalekshmi.m.s@gmail.com  
 
Source of Monetary or Material Support  
Department of Organon of Medicine and Homoeopathic Philosophy, White Memorial Homoeo Medical College and Hospital Attoor, Veeyanoor PO kanniyakumari, Tamilnadu pincode 629177 
 
Primary Sponsor  
Name  White Memorial Homoeo Medical College and Hospital  
Address  White Memorial Homoeo Medical College and Hospital Attoor Veeyanoor PO Tamilnadu 629177 
Type of Sponsor  Private 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 Dhanalekshmi m s  White Memorial Homoeo Medical College and Hospital   Department of Organon of Medicine and Homoeopathic Philosophy OPD Unit,IPD Unit, Health camps and Peripheral centers
Kanniyakumari
TAMIL NADU 		 9633736136

dr.dhanalekshmi.m.s@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee White Memorial Homoeo Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N398||Other specified disorders of urinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anti- miasmatic Medicines  Minimum Dose According to Homoeopathic Principle  
Intervention  Anti-Miasmatic Medicines   Each case will be reviewed at 1 month intervel or as per their need in case of emergency and it will be followed up for a period of 6 months 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Mild to severe cases 
 
ExclusionCriteria 
Details  Age more than 70 years
Patients with complete urinary retention/stone formation and gross bilateral hydronephrosis
Urethral stricture
Patients with other systemic or neurological disorders  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of Homoeopathic anti- miasmatic medicine in benign prostatic hyperplasia   Before and after scan report yearly once
Before and after ipss score sheet yearly once 
 
Secondary Outcome  
Outcome  TimePoints 
After one year,follow up will be taken every month and further treatment will be done if necessary   1year 
 
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 2 
Date of First Enrollment (India)   10/07/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.dhanalekshmi.m.s@gmail.com].

  6. For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Minimum of 30 cases will be selected by purposive sampling
Cases will be taken in details and recorded in the pre structured case record from the Inpatient department and Outpatient department and peripheral centers of White Memorial Homoeo Medical College and Hospital
Diagnosis will be done by clinical symptoms, DRE and Ultrasonography
Before enrolment written informed consent will be taken from the patients
Analysed cases will be repertorized and suitable anti-medicines will be selected and given This is based on Hahnemann‘s classification of chronic diseases
Repetition of the medicine will be done according to the improvement of treatment
Assessment will be done using IPSS score once in a month
Evaluate the pre and post value of before and after study
 
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