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CTRI Number  CTRI/2024/11/076277 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Individualized Homoeopathic Medicine in treating Dermatitis 
Scientific Title of Study   A clinical study to evaluate the effectiveness of Individualized Homoeopathic Medicines in cases of Dermatitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravi Kumar Yogi 
Designation  MD Scholar Department of Practice of Medicine 
Affiliation  Swasthya Kalyan Homoeopathic Medical College And Research Centre 
Address  Department of Practice of Medicine, Swasthya Kalyan Homoeopathic Medical College And Research Centre,10A, Sitapura Industrial Area Sitapura,jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7023392077  
Fax    
Email  ravikumaryogi7023@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagdish Thebar 
Designation  Professor and HoD, Department of Practice of Medicine 
Affiliation  Swasthya Kalyan Homoeopathic Medical College And Research Centre 
Address  Department of Practice of Medicine, Swasthya Kalyan Homoeopathic Medical College And Research Centre,10A, Sitapura Industrial Area Sitapura,jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9829391362  
Fax    
Email  thebarjagdish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ravi Kumar Yogi 
Designation  MD Scholar Department of Practice of Medicine 
Affiliation  Swasthya Kalyan Homoeopathic Medical College And Research Centre 
Address  Department of Practice of Medicine, Swasthya Kalyan Homoeopathic Medical College And Research Centre,10A, Sitapura Industrial Area Sitapura,jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7023392077  
Fax    
Email  ravikumaryogi7023@gmail.com  
 
Source of Monetary or Material Support  
Swasthya Kalyan Homoeopathic Medical College And Research Centre,10A, Sitapura Industrial Area Sitapura,Jaipur, Rajasthan, India PIN- 302022 
 
Primary Sponsor  
Name  Swasthya Kalyan Homoeopathic Medical College And Research Centre 
Address  Swasthya Kalyan Homoeopathic Medical College And Research Centre,10A, Sitapura Industrial Area Sitapura,Jaipur, Rajasthan, India PIN- 302022 
Type of Sponsor  Research institution and hospital 
 
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 Ravi Kumar Yogi  Swasthya Kalyan Homoeopathic Medical College And Research Centre  Department of Practice of Medicine, Swasthya Kalyan Homoeopathic Medical College And Research Centre,10A, Sitapura Industrial Area Sitapura,Jaipur, Rajasthan, India PIN 302022
Jaipur
RAJASTHAN 		 7023392077

ravikumaryogi7023@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Swasthya Kalyan Homoeopathic Medical College Institutional Ethics Committee  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  Homoeopathic medicines  2/UA/HPM/2011,oral route,doses and frequency will be according to the susceptibility of the patient for 42 days duration 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  0.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All age group
Both sexes
Pregnant and lactating mothers are also included
Symptomatic cases, that are pre-diagnosed and new case diagnosed. 
 
ExclusionCriteria 
Details  Cases who refuse to give their consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find Effectiveness of individualized Homoeopathic medicine in cases of dermatitis with the
help of eczema area and severity index (EASI) score.
 		 one year
 
 
Secondary Outcome  
Outcome  TimePoints 
To prepare the Homoeopathic therapeutic compendium in treatment of dermatitis.  12 MONTHS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   16/11/2024 
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   This study is a clinical interventional and non blind to see the effectiveness of Homoeopathic medicines in the cases of Dermatitis and to prepare the Homoeopathic therapeutics for treatment of dermatitis.this study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Reasearch Centre, Jaipur. 60 patients will be enrolled in this study using purposive sampling. the study duration will be of 12 months. All age group and both sexes will  be enrolled in this study. The follow up will be assessed weekly for 6 visits. The pre and post assessment will be done using Eczema Area and Severity Index. The study will help to assess the role of individualized homoeopathic medicines in cases of Dermatitis. 
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