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CTRI Number  CTRI/2025/07/090030 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment in managing chronic hand eczema patients.  
Scientific Title of Study   THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN MANAGEMENT OF CHRONIC HAND ECZEMA – A QUASI-EXPERIMENTAL 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 Anjana Krishnan 
Designation  Post graduate trainee ,Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health, Kottayam  
Address  National Homoeopathic Research Institute in Mental Health,Second floor,Room no-146,Department of Practice of medicine,Sachivothamapuram P.O,Kurichy,Kottayam,Kerala,India,686532

Kottayam
KERALA
686532
India 
Phone  9947807169  
Fax    
Email  anjanakrishnankutty15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPDastagiri 
Designation  Associate Professor .R.O,S-2 Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health, Kottayam  
Address  National Homoeopathic Research Institute in Mental Health,Second floor,Room no-144,Department of practice of medicine,Sachivothamapuram P.O,Kurichy,Kottayam,Kerala,686532 .India

Kottayam
KERALA
686532
India 
Phone  9000444409  
Fax    
Email  drdastagirinhrimh@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrPDastagiri 
Designation  Associate Professor .R.O,S-2 Department of Practice of Medicine 
Affiliation  National Homoeopathy Research Institute in Mental Health, Kottayam  
Address  National Homoeopathic Research Institute in Mental Health,Second floor,Room no-144,Department of practice of medicine.Sachivothamapuram P.O,Kurichy,Kottayam,Kerala,686532 .India

Kottayam
KERALA
686532
India 
Phone  9000444409  
Fax    
Email  drdastagirinhrimh@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr.Anjana Krishnan 
Address  National Homoeopathy Research Institute in Mental Health,Sachivothamapuram P.O ,Kurichy Kottayam,686532 
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 Anjana Krishnan  National Homoeopathy Research Institute in Mental Health, Kottayam   OPD,IPD,Peripheral camps and units, Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kottayam ,Kerala 686532
Kottayam
KERALA 		 9947807169

anjanakrishnankutty15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L20-L30||Dermatitis and eczema,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic medicine  Case taking will be conducted using a standard case sheet proforma designed for this study followed by the analysis and evaluation of symptoms. The totality will be framed and repertorization will be performed using the Synthesis Repertory and RADAR OPUS SOFTWARE. After consulting Materia Medica an individualized homoeopathic remedy will be selected. The indicated medicine will be administered in 6C potency and the dosage and frequency of medicine will be determined based on the severity of the condition. The potency will raised during the follow-up visits as per the need of the case. Patients will be instructed on how to take the medicine. The treatment will be continued, adjusted, or discontinued based on the Patients progress and following homoeopathic principles. The Patient will be advised to follow up every month. The HECSI score , the QOLHEQ scale and photographs of both hands will be assessed every three months. If there is no significant reduction in the HECSI score after two months, the case will be retaken and an indicated remedy will be given. If there is an improvement in symptoms and the HECSI Score the Patient will be kept under a placebo. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants presenting with symptoms of like erythema ,infiltration ,vesicles, fissures, scaling and edema. Age group between 18-65 years and of any gender.  
 
ExclusionCriteria 
Details  Participants with psoriasis,Tinea mannum,Lichen planus,Mycosis fungoides,Scabies..
Pregnant and lactating women.
Participants with known severe systemic illness, malignancy.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in HECSI Score base line 3rd,6th, 9th, 12th month for interpreting the disease activity in hand eczema.  At the baseline and at the end of study 
 
Secondary Outcome  
Outcome  TimePoints 
:Changes in the severity of skin lesion in hand eczema using Quality of life questionnaire of hand eczema-baseline 3rd ,6th ,9th and 12th month .  The questionnaires and scales will be administered every 3 rd month from baseline till the end of the study 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   15/07/2025 
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anjanakrishnankutty15@gmail.com].

  6. For how long will this data be available start date provided 15-07-2025 and end date provided 11-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is a quasi experimental study, find out the effectiveness of individualized homoeopathic medicine in management of  chronic hand eczema for 18 months(enrolment period 6 months, intervention period 12 months) that will be conducted in National Homoeopathic Research Institute in Mental health Kottayam, Department of Practice of Medicine. The primary outcome measures is to fond out changes in HECSI Score baseline 3rd ,6th, 9th and 12 th month for interpreting the disease activity in hand eczema. 
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