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CTRI Number  CTRI/2024/12/077819 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Other (Specify) [Arsenicum Sulphuricum Flavum]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Homoeopathic Medicines in treatment of Vitiligo 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicines vs Arsenicum Sulphuricum Flavum in improving the quality of life among vitiligo patients: An open label randomised controlled clinical trial  
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 Ankita Jain 
Designation  PG Scholar 
Affiliation  Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh 
Address  Practice Of Medicine Department, 3rd Floor, Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh

South West
DELHI
110021
India 
Phone  09582990982  
Fax    
Email  drankitajain1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neena Mehan 
Designation  Professor & HOD, Department of Practice of Medicine 
Affiliation  Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh  
Address  Practice Of Medicine Department, 3rd Floor, Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh

South West
DELHI
110021
India 
Phone  9811578570  
Fax    
Email  neenamehan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Jain 
Designation  PG Scholar 
Affiliation  Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh 
Address  Practice Of Medicine Department, 3rd Floor, Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh

South West
DELHI
110021
India 
Phone  09582990982  
Fax    
Email  drankitajain1995@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh, New Delhi- 110021 
 
Primary Sponsor  
Name  Dr Ankita Jain 
Address  Dr B R Sur Homoeopathic Medical College Hospital And Research Centre, Nanakpura Motibagh, New Delhi - 110021 
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 Ankita Jain  Dr B R Sur Homoeopathic Medical College Hospital And Research Centre  OPD Room no 05 (ground floor) & IPD (first floor), Dr B R SUR, Homoeopathic medical college, hospital & Research Centre, Nanakpura, Motibagh, New Delhi - 110021
South West
DELHI 		 9582990982

drankitajain1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The institutional ethics committee Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Motibagh New Delhi 110021  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arsenicum Sulphuricum Flavum  Started with 6c potency in each case. Route of drug administration - oral. Repetition of dosages will be done on the basis of requirement of case as per the homeopathic principles. Each case will be followed up at a regular interval of 4 weeks or as per the requirement. 
Comparator Agent  Individualized Homoeopathic Medicine   A well selected Individualized homoeopathic remedy on the basis of case taking, analysis, evaluation, totality and repertorization will be carried out as per the homeopathic principles. Route of drug administration - oral. Each case will be followed up at a regular interval of 4 weeks or as per the requirement. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient suffering from vitiligo.
2.Both sexes of age group 5 years to 65 years.
3.Patient willing to give voluntary written informed assent and consent (greater than 18 years). 
 
ExclusionCriteria 
Details  1.Vitiligo patients suffering from any life-threatening illness who are terminally ill, under immuno-suppressive treatment or self-reported immuno-compromised state.
2.Patients of malignancy or too sick for consultation.
3.Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening illness affecting quality of life/any organ failure.
4.Pregnant ladies are excluded.
5.Unwilling to take part and not giving consent to join the study. Patients unable to comply with the study protocol.
Substance abuse and or dependence. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that there will be repigmentation in depigmented area of skin with the individualized homoeopathic medicines compared to Arsenicum Sulphuricum Flavum in vitiligo.  At baseline (0 weeks) and after 9 months(36 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that there will be improvement in patient’s outcome and general well being, without any substantial medicinal adverse effects hence an improvement in quality of life (DLQI) & significant reduction in VASI scores and Re-pigmentation on hypopigmented/ depigmented patches.  At baseline (0 weeks) and after 9 months (36 weeks) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   17/12/2024 
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="1"
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   This study compares the effectiveness of individualized homeopathic medicines and Arsenicum Sulphuricum Flavum in treating patients with Vitiligo, aged 05 years- 65 years. Patients will be randomly assigned to receive either individualized homeopathic medicines or Arsenicum Sulphuricum Flavum. The study will measure the outcomes using VASI (Vitiligo Area  Severity Index) and DLQI (Dermatology Life Quality Index) scores. The primary goal is to compare the effectiveness of these two approaches in managing vitiligo, improving quality of life, and reducing disease severity. The results will provide valuable insights into the effectiveness of homeopathic approaches in treating Vitiligo. 
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