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CTRI Number  CTRI/2024/03/064462 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathy for Erectile Dysfunction: Individualized Treatment Study.  
Scientific Title of Study   The Effectiveness of Individualized Homoeopathic Remedies selected using Boger Boenninghausens Characteristics & Repertory in Erectile Dysfunction: An Open label Prospective Clinical 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  Kothapally Sugnan 
Designation  PG student 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block– GE, Sector– III, Salt Lake, Kolkata– 700106, West Bengal, India

Kolkata
WEST BENGAL
700106
India 
Phone  8074893649  
Fax    
Email  sugnankothapalli5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Avijit Shee Burman 
Designation  Professor and HOD, Department of Forensic Medicine and Toxicology 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block– GE, Sector– III, Salt Lake, Kolkata– 700106, West Bengal, India

Kolkata
WEST BENGAL
700106
India 
Phone  9433392108  
Fax    
Email  asheeburman@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Avijit Shee Burman. 
Designation  Professor and HOD, Department of Forensic Medicine and Toxicology 
Affiliation  National Institute of Homoeopathy 
Address  National Institute of Homoeopathy Block– GE, Sector– III, Salt Lake, Kolkata– 700106, West Bengal, India

Kolkata
WEST BENGAL
700106
India 
Phone  9433392108  
Fax    
Email  asheeburman@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy Block– GE, Sector– III, Salt Lake, Kolkata– 700106, West Bengal, India 
 
Primary Sponsor  
Name  Kothapally Sugnan 
Address  National Institute of Homoeopathy Block– GE, Sector– III, Salt Lake, Kolkata– 700106, West Bengal, India 
Type of Sponsor  Other [self] 
 
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 Avijit Shee Burman  National Institute of Homoeopathy  Room no.10, Department of Repertory, Block– GE, Sector– III, Salt Lake, Kolkata– 700106, West Bengal, India
Kolkata
WEST BENGAL 		 9433392108

asheeburman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Homoeopathy-Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N528||Other male erectile dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Remedy  a) Individualized Homoeopathic Remedy selected using Boger Boenninghausens Characteristics & Repertory b) Remedies selected will be prescribed in Centesimal or LM Potency c) Oral medication will be given  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. Subjects of all socio-economic status and all religions.
2. Clinically diagnosed cases of erectile dysfunction using the International Index of Erectile
Function (IIEF-5) questionnaire.
3. Willingness to actively participate in the study, attend regular follow-up assessments, and
adhere to the prescribed homeopathic treatment plan.
4. literate patients who can read Hindi, English, or Bengali and can self-assess the questionnaire
will be considered.
5. Patients who have already had other method of treatment but now intend to undergo
homoeopathic treatment, after providing a gap of four weeks as wash-out period
6. No homeopathic treatment for any ailment including erectile dysfunction within the past 2
months.
7. Stable overall health without acute or severe medical conditions. 
 
ExclusionCriteria 
Details  1. Severe cardiovascular diseases, such as uncontrolled hypertension or recent myocardial
infarction.
2. Current suffering from severe, acute, life-threatening illnesses or Psychiatric conditions
3. Patients with congenital genital defects.
4. Pelvic or genital surgery within the past six months.
5. Current use of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction
6. Inability or unwillingness to comply with scheduled follow-up visits and assessment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of the impact of Homoeopathic treatment on the symptoms and severity of
Erectile Dysfunction, utilizing the IIEF-5 questionnaire. 		 Baseline and 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
assessment of the overall improvement in quality of life following Homoeopathic
interventions, measured through the 36-Item Short Form Survey Instrument (SF-36) 		 Baseline and 6th month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   02/04/2024 
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="9"
Days="29" 
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  

Erectile dysfunction (ED) is a prevalent concern worldwide, impacting men’s physical health and overall quality of life. It is characterized by the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. While not life-threatening, ED leads to withdrawal from sexual intimacy, reduced quality of life, and decreased work productivity. With various treatment modalities available, there is growing interest in exploring alternative therapeutic approaches. This prospective study investigates the effectiveness of individualized homeopathic remedies in managing Erectile Dysfunction, using Boger Boenninghausen’s Characteristics & Repertory for remedy selection. The study aims to assess the impact of homeopathic treatment on Erectile Dysfunction symptoms and severity, using the International Index of Erectile Function (IIEF-5) questionnaire. Additionally, it seeks to evaluate the overall improvement in quality of life following homeopathic interventions, measured through the Rands 36-Item Short Form Survey Instrument (SF-36).

 
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