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CTRI Number  CTRI/2024/06/068342 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Other 
Public Title of Study   To study the role of homoeopathic medicines in cases of eczema 
Scientific Title of Study   A clinical study to assess the effectiveness of individualised Homoeopathic medicine in cases of 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 komalben Dilipsinh Vansadiya 
Designation  PG scholar 
Affiliation  Rajkot Homoeopathic Medical College Parul University 
Address  Department of practice of medicine, rajkot homoeopathic medical college, b/h jainath petrol pump gondal road rajkot 360002

Rajkot
GUJARAT
360002
India 
Phone  9737461271  
Fax    
Email  komalvansadiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailendra Bhamar 
Designation  proffesor (practice of medicine) & PG GUIDE 
Affiliation  Rajkot Homoeopathic Medical College Parul University 
Address  Department of practice of medicine, rajkot homoeopathic medical college, b/h jainath petrol pump gondal road rajkot 360002

Rajkot
GUJARAT
360002
India 
Phone  9737461271  
Fax    
Email  shailendra.bhamar17970@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr komalben Dilipsinh Vansadiya 
Designation  PG scholar 
Affiliation  Rajkot Homoeopathic Medical College Parul University 
Address  Department of practice of medicine, rajkot homoeopathic medical college, b/h jainath petrol pump gondal road rajkot 360002

Rajkot
GUJARAT
360002
India 
Phone  9737461271  
Fax    
Email  komalvansadiya@gmail.com  
 
Source of Monetary or Material Support  
Rajkot Homoeopathic Medical College,behind jainath complex makkam chowk gondal road, rajkot 360002,Gujarat India 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College Parul UNiversity 
Address  Behind Jainath Complex, makkam chowk, gondal road,Rajkot 360002 , Gujarat,India 
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 Komalben Dilipsinh Vansadiya  Rajkot Homoeopathic Medical College attached with Sainath Medical College,Parul University  Behind jainath complex,makkam chowk,gondal road,Rajkot Department : Practice of Medicine Division -A Room Number - 104
Rajkot
GUJARAT 
9737461271

Komalvansadiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Human Research - Rajkot Homoeopathic Medical College (RHMC),Parul University, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Individualized Homoeopathic Medicine selected on the basis of totality of symptoms Doses based on the Susceptibility of the patients in 30,200 or 1M potency. Route of Administration is orally. frequency of repeatation depending upon symptoms 7days,15days,1month total duration upto 3 months  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  70.00 Year(s)
Gender  Both 
Details  I. Samples of both sexes and all ages will be taken.
II. Cases of chronic eczema will be taken.
 
 
ExclusionCriteria 
Details  I. Life-threatening complications are excluded in this study.
II. Patient with immune compromised are excluded in this study.
III. Pregnant and lactating females are excluded in this study.
IV. Patient with other skin diseases with same manifestation are excluded.
v. case with irregular follow up. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To Assess The Effectiveness Of Individualized Homoeopathic Medicine In Case Of Eczema  12 Weeks, 24 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To Check The Patients Response To The Medicine  12 Weeks, 24 Weeks 
 
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 2 
Date of First Enrollment (India)   21/06/2024 
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)   Other (Terminated) 
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   NEED FOR STUDY : 

Eczema is a skin disease which is associated with many cosmetic concern for the person including feeling of embracement and stigmatization as well as challenges to opportunities and interpersonal relationships. Eczema flare up may causes a person to stressed, anxious or depressed. They may also experience fatigue and social withdrawal due to their physical and mental health symptoms. People with eczema may feel depressed, ashamed or hopeless about their situation, which can affect their mental well being and also withdrawal or avoid social activities, physical activities and relationships. Children with eczema feels embraces at school and especially when the affected areas are difficult to cover such as face, scalp, hands. In adults also very difficult situation in the person who is working in good professional job. Natural treatment of eczema currently is of considerable interest among dermatologist. For the holistic natural treatment of eczema classic homoeopathic medicines are useful. The major advantage of homoeopathic medicine in the conventional dermatological practice include low cost, easily availability, easy to administration, patient acceptability and reduction in the topical steroid use. Eczema was estimated to affect 245 million people globally in 2015 or 3.34 percentage population. Atopic eczema is most common type and may generally starts in childhood. Research suggest that homoeopathic treatment for allergies may be ideal because this type of therapy acts as an immunoregulator, immunomodulator, possibly regulating or reviving the immune system. Homoeopathy being one of the most effective line of treatment, it can be helpful in treating eczema but reversal of it is also possible in early stages with proper Homoeopathic medication and lifestyle modification.  

 
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