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CTRI Number  CTRI/2024/10/075321 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Atopic Dermatitis with Homoeopathic Medicine 
Scientific Title of Study   PROSPECTIVE STUDY ON EFFECTIVENESS OF HOMOEOPATHIC MEDICINE IN THE TREATMENT OF ATOPIC DERMATITIS IN ADULTS USING 50 MILLESIMAL POTENCY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KIRTHANA L 
Designation  PG Scholar 
Affiliation  White memorial homoeo medical college hospital 
Address  Department of Materia Medica White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari District

Ramanathapuram
TAMIL NADU
629177
India 
Phone  9940535497  
Fax    
Email  kirthuteddy17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasobh M P 
Designation  Associate Professor 
Affiliation  White memorial homoeo medical college hospital 
Address  Department of Materia Medica White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari District

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9447746688  
Fax    
Email  drprasobhmp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KIRTHANAL 
Designation  PG Scholar 
Affiliation  White memorial homoeo medical college hospital 
Address  Department of Materia Medica White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari District

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9940535497  
Fax    
Email  kirthuteddy@gmail.com  
 
Source of Monetary or Material Support  
White memorial homoeopathic medical college Attoor veyanoor kanniyakumari distric 629177 
 
Primary Sponsor  
Name  White memorial homoeopathic medical college 
Address  Attoor veyanoor kanniyakumari distric 629177 
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 KIRTHANA L  White memorial homoeo medical college hospital  Materia Medica department OPD IPD and periphery centers of WMHMCH kanniyakumari
Kanniyakumari
TAMIL NADU 
9940535497

kirthuteddy17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee White memorial homoeo medical college hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoepathic medicine in 50 millesimal potency  A single homoeopathic medicine in 50 millesimal potency is prescribed as per the law of homeopathy.Medicine will be started in 0/1 potency and will be given in increasing dose and will be repeated according to the neeed of case  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed with Atopic dermatitis as per Hanifin and Rajka criteria
Subjects of both sexes
Age group of 18-40 years 
 
ExclusionCriteria 
Details  Cases of psychiatric illness
Pregnant and lactating women
Already under treatment (medicinal/surgical/both) for any other chronic disease within last 6 months
Immunocompromised patients with HIV and cancerous
manifestation  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the improvement in Atopic dermatitis in adults
using PO-SCORAD scale 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Homoeopathic medicines for Atopic dermatitis in 50 millesimal potency  1 year 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/10/2024 
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="0"
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   A PROSPECTIVE STUDY ON EFFECTIVENESS OF HOMOEOPATHIC MEDICINE IN THE TREATMENT OF ATOPIC DERMATITIS IN ADULTS USING 50 MILLESIMAL POTENCY
Atopic Dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease that primarily affects young children but also an important adult dermatological disease, affecting approximately 2-3% of adults. Atopic dermatitis (AD) is frequently linked with concurrent atopic disorders, such as food allergies, asthma, and allergic rhinoconjunctivitis. Moreover, there is an association with eosinophilic conditions, including eosinophilic esophagitis and eosinophilic gastroenteritis. It has been proposed that AD is the first step in an “atopic march”.Atopic dermatitis remains a serious health concern, and in many countries, particularly in the developing world, the disease is still very much on the rise. Girls are slightly more likely to develop AD. It has variable rates of remission, with many patients continuing or recurring with symptoms into adulthood. AD is under ICD-11-EA-80.The 50 millesimal potency is a powerful and mildest way of administration of medicine in the least material form but at the same time increased in power by each dynamization 50,000 times.
 
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