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CTRI Number  CTRI/2025/08/092664 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the effects of homoeopathic treatment on symptoms and quality of life in patients with eczema. 
Scientific Title of Study   Effectiveness of individualized homoeopathic treatment on quality of life and clinical symptoms in eczema  
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 ANGELA B WILLIAMS 
Designation  JUNIOR RESIDENT  
Affiliation  Sarada krishna homoeopathic medical college 
Address  Room no 403, IIIrd floor, college building, Department of organon of medicine, sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamilnadu.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  8281829766  
Fax    
Email  angelabwilliams766@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MANOJ NARAYAN V 
Designation  PROFESSOR 
Affiliation  Sarada krishna homoeopathic medical college 
Address  Room no 403, IIIrd floor, College Building, Department of Organon of Medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamilnadu.
Room no 403, IIIrd floor, College Building, Department of Organon of Medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamilnadu.
Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MANOJ NARAYAN V 
Designation  PROFESSOR 
Affiliation  Sarada krishna homoeopathic medical college 
Address  Room no 403, IIIrd floor, College Building, Department of Organon of Medicine, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district, Tamilnadu.

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Source of Monetary or Material Support  
Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamilnadu,India 629161 
 
Primary Sponsor  
Name  Post graduate research funded by college 
Address  Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamilnadu.629161 
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 ANGELA B WILLIAMS  Sarada Krishna Homoeopathic Medical College  Room no 403, IIIrd floor, Department of Organon, Opd, Ipd, Rural Health Centres, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, TamilNadu,629161.
Kanniyakumari
TAMIL NADU 
8281829766

angelabwilliams766@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee sarada krishna homoeopathic medical college   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 
Comparator Agent  Nil  Nil 
Intervention  Similimum based on individualized homoeopathic principle in eczema.   Case taking, selection and administration of medicine will be based on Homoeopathic principles. Homoeopathic similar remedy is prescribed for the totality of symptoms erected based on individualization. The pre-assessment is conducted during the initial visit, followed by regular follow-up every 14 days. The cases are being observed over a period of 6 months. Post-assessments will be done at the end of 3 months and again at the end of 6 months using the DLQI and EASI. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group between 16 years to 65 years.
Both sexes.
Patients of all socioeconomic types. 
 
ExclusionCriteria 
Details  Pregnant and Lactating women.
Patients with serious systemic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the quality-of-life improvement in patients with eczema, as measured by the dermatology life quality index (DLQI), with homoeopathic medications.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the reduction in severity of symptoms of eczema with homoeopathic medicines.  6 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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/ Phase 4 
Date of First Enrollment (India)   20/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Eczema is a skin condition that extends beyond physical symptoms, causing emotional distress, social stigma, and impacts on daily life, including career and personal relationships. The prevalence of Eczema ranged from 0.98% to 9.2% in studies including paediatric and adult patients. The cost of medications was reported to be the major contributor to the economic burden associated with Eczema. This prospective study aims to evaluate the effectiveness of individualized homoeopathic treatment on the quality of life and symptom severity in patients diagnosed with Eczema. A total of 28 patients, aged between 16 to 65 years and of both sexes, will be enrolled from the Outpatient Department (OPD), Inpatient Department (IPD), and affiliated rural health centres of Sarada Krishna Homoeopathic Medical College. Each patient will undergo a thorough case-taking process, and homoeopathic medicines will be prescribed based on the totality of symptoms. The primary outcome measures for the study include the Dermatology Life Quality Index (DLQI), a validated tool to assess the impact of skin diseases on patients’ daily lives, and the Eczema Area Severity Index (EASI), which is employed to objectively measure the severity of eczema symptoms. The pre-assessment is conducted during the initial visit, followed by regular follow-up every 14 days. The cases are being observed over a period of 6 months. Post-assessments will be done at the end of 3 months and again at the end of 6 months using the DLQI and EASI. All relevant clinical data and patient responses will be systematically documented throughout the study. This study aims to provide observational evidence on the role of individualised homoeopathic treatment in managing eczema and improving patients’ quality of life, thereby contributing to integrative dermatological care. The outcomes may support further research into the potential benefits of homoeopathy in chronic dermatological conditions.

 
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