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CTRI Number  CTRI/2023/06/053615 [Registered on: 07/06/2023] Trial Registered Prospectively
Last Modified On: 28/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   The efficacy of Individualized Homoeopathic medicine in case of eczema  
Scientific Title of Study   To evaluate the efficacy of Individualized Homoeopathic medicine in case of eczema  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin kumar singh  
Designation  Assistant professor Dept of Materia Medica 
Affiliation  RBTS govt homeopathic medical college and hospital  
Address  RBTS Govt Homeopathic medical college muzaffarpur Ram dayalu road Bihar

Muzaffarpur
BIHAR
842002
India 
Phone  9430001076  
Fax    
Email  drpravinsingh83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravin kumar singh  
Designation  Assistant professor Dept of Materia Medica 
Affiliation  RBTS govt homeopathic medical college and hospital  
Address  RBTS Govt Homeopathic medical college muzaffarpur Ram dayalu road Bihar

Muzaffarpur
BIHAR
842002
India 
Phone  9430001076  
Fax    
Email  drpravinsingh83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pravin kumar singh 
Designation  Assistant professor Dept of Materia Medica  
Affiliation  RBTS govt homeopathic medical college and hospital  
Address  RBTS Govt Homeopathic medical college and hospital muzaffarpur Bihar 842002 near Ramdayalu nagar station muzaffarpur Bihar

Muzaffarpur
BIHAR
842002
India 
Phone  9430001076  
Fax    
Email  drpravinsingh83@gmail.com  
 
Source of Monetary or Material Support  
RBTS GOVT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL MUZAFFARPUR  
 
Primary Sponsor  
Name  RBTS GOVT HOMEOPATHIC MEDICAL COLLEGE AND HOSPITAL MUZAFFARPUR  
Address  Near Ramdayalu nagar station muzaffarpur bihar 842002 
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 Pravin Kumar Singh  OPD of Dept of Dermatology of RBTS Govt Homoeopathic Medical College and Hospital   Near Ramdayalu Nagar station PO Ramna Muzaffarpur Bihar 842002
Muzaffarpur
BIHAR 
9430001076

drpravinkumarsingh83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  patient of both the sexes
patient presenting with the symptoms of eczema
is group between 20-50years of age
having written consent to participate in the study
 
 
ExclusionCriteria 
Details  case with gross pathological evidences
patients having diabetes hypertension cardiovascular diseases
psychiatric patient
patients required emergency medical intervention patience
pregnant women and lactating 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of the patient   0 to 3 month  
 
Secondary Outcome  
Outcome  TimePoints 
All the outcome will
be assessed by Atopic Dermatitis Severity Index (ADSI) at baseline (0 month) and after 3 months. 
0 to 3 month  
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   16/06/2023 
Date of Study Completion (India) 30/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
No 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Eczema is a chronic, complex, often relapsing inflammatory skin disease. Eczema derives from Greek Word ‘to boil’ which means tiny vesicles. The clinical presentation of eczema includes pruritus, xerosis, and eczematous lesions, and its pathology is characterized by interactions between skin barrier defects and immune dysregulation. There is a consistent association of eczema with other atopic and allergic conditions including asthma and atopic rhinitis. Primary lesions of eczema may include papules, erythematous macules, and vesicles which can coalesce to form patches and plaques. In severe eczema, secondary lesions from infection or excoriation, marked by weeping and crusting, may predominate. Long-standing dermatitis is dry and is characterized by thickened, scaling skin (Lichenification)

Eczema is most commonly seen in infancy, with female predominance of eczema presentation occurring during the reproductive period of 15-49yrs.In the overall population, the 12-month adult prevalence of eczema was 4.4% in the EU with individual country ranges of 2.2%. Prevalence rates were higher among females than among males.

With the help of homoeopathy, we will evaluate the effect of skin disease only various organ like lungs, liver, renal etc. Allopathic medicine should destroy the local symptom by the tropical application of external remedies, under the belief that he cures the whole disease, where nature makes up for its loss by rousing the internal malady and other symptoms that previously existed in a latent state side by side with the local affection.

 
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