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CTRI Number  CTRI/2025/02/080138 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Use Of Homoeopathy In Varicose Vein 
Scientific Title of Study   Role Of The Homoeopathic Remedies Using Synthesis Repertory In Varicose Vein: 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  Dr Nikita Yadav 
Designation  PGT Trainee 
Affiliation  National Institute Of Homeopathy 
Address  OPD Room No 10,Department Of Repertory, National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake , Kolkata Kolkata WEST BENGAL 700106 India

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  9131150437  
Fax    
Email  nikitayadav8283@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binod Kumar Bhagat 
Designation  Professor 
Affiliation  National Institute Of Homeopathy 
Address  OPD Room No 10,Department Of Repertory, National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake , Kolkata Kolkata WEST BENGAL 700106 India

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  8210003714  
Fax    
Email  dr.binodkbhagat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Binod Kumar Bhagat 
Designation  Professor 
Affiliation  National Institute Of Homeopathy 
Address  OPD Room No 10,Department Of Repertory, National Institute Of Homoeopathy, Block GE, Sector 3, Salt Lake , Kolkata Kolkata WEST BENGAL 700106 India

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  08210003741  
Fax    
Email  dr.binodkbhagat@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Homeopathy, Block GE, Sector 3, Salt Lake, Kolkata-700106,West Bengal, India 
 
Primary Sponsor  
Name  National Institute Of Homeopathy 
Address  National Institute Of Homeopathy, Block GE, Sector 3, Salt Lake, Kolkata-700106,West Bengal, 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 Binod Kumar Bhagat  National Institute Of Homeopathy  OPD No 10, Department Of Repertory, Block GE, Sector 3, Salt Lake Kolkata WEST BENGAL
North Twentyfour Parganas
WEST BENGAL 		 8210003741

dr.binodkbhagat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute Of Homeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Individualized Homoeopathic medicine  Indicated individualized homoeopathic Medicine will be prescribed after proper case taking and Repertorisation of the case using rubrics within synthesis repertory. Dose and frequency of the selected Medicine will be as per the susceptibility of the patient. Follow up will be done monthly till 6 months from the baseline. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient clinically diagnosed with varicose vein age group 18-60 yr of both genders.
2. subjects of all socioeconomic and religions.
3.subject willing to participate in the study after submitting the written informed consent form.
4. Patient who can read, write and understand English, Hindi , Bengali. 
 
ExclusionCriteria 
Details  1. Secondary varicose veins (secondary to trauma, DVT, intra- abdominal pathology etc).
2. Associated deep venous incompetence on imaging.
3.Any known chronic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Venous Clinical Severity Scoring  Baseline And 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Socio-demographic data  Baseline And 6 Months 
 
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   Phase 2 
Date of First Enrollment (India)   17/02/2025 
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)   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   Varicose veins are enlarged, twisted superficial veins found in the legs. They occur due to malfunctioning valves within the veins and a loss of elasticity in the vein walls, which leads to blood pooling and vein enlargement.
 1. Samples will be selected following preliminary and detailed screening using specified selection criteria.
 2. Inclusion and exclusion criteria are strictly followed.
 3. After consideration of dropout cases, a minimum 40 patients will be enrolled for the study. 
 4. Case-taking will be done as per the strict homoeopathic principle.
 5. Baseline scoring will be taken using VCSS. 
 6. Analysis and evaluation of each case will be done. 
 7. Miasmatic analysis will be done. 
 8. Repertorization will be done in Synthesis Repertory.
 9. Final selection of the remedy will be done after consultation with Materia Medica, 
10. Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles. 
11. General (non-medicinal) management including appropriate diet and regimen will be advised. 
12. Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. 
13. The baseline data will be compared with the data obtained After 6th month. 
14. The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter.
 
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