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CTRI Number  CTRI/2025/02/080069 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Treatment of Urticaria 
Scientific Title of Study   A clinical study on the efficacy of Individualized constitutional medicine in cases of Urticaria along with miasmatic study 
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 Neeharika Soni 
Designation  PG Scholar Department of Organon of Medicine and Homoeopathic Philosophy 
Affiliation  Department of Organon of Medicine and Homoeopathic Philosophy 
Address  Room Number 08 Academic Block RBTS Govt Homoeopathic Medical College And Hospital RDS Chowk Ramdayalu Nagar Muzaffarpur

Muzaffarpur
BIHAR
842002
India 
Phone  8178340653  
Fax    
Email  dr.neeharikasoni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeharika Soni 
Designation  PG Scholar Department of Organon of Medicine and Homoeopathic Philosophy 
Affiliation  Department of Organon of Medicine and Homoeopathic Philosophy 
Address  Room Number 08 Academic Block RBTS Govt Homoeopathic Medical College And Hospital RDS Chowk Ramdayalu Nagar Muzaffarpur

Muzaffarpur
BIHAR
842002
India 
Phone  8178340653  
Fax    
Email  dr.neeharikasoni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shashi Bhushan Singh 
Designation  Associate Professor Department of Gynaecology and Obstetrics 
Affiliation  RBTS Govt Homoeopathic Medical College And Hospital 
Address  Room Number 08 Academic Block RBTS Govt Homoeopathic Medical College And Hospital RDS Chowk Ramdayalu Nagar Muzaffarpur

Muzaffarpur
BIHAR
842002
India 
Phone  7739645479  
Fax    
Email  singh.sb20@gmail.com  
 
Source of Monetary or Material Support  
RBTS Govt Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur Bihar India 842002 
 
Primary Sponsor  
Name  RBTS Govt Homoeopathic Medical College and Hospital 
Address  RDS Chowk Ramdayalu Nagar Muzaffarpur Bihar India 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 Neeharika Soni  RBTS Govt Homoeopathic Medical College and Hospital  OPD 1 Medicine OPD 5 Organon Dept OPD 6 Materia Dept OPD 7 Repertory RBTS Govt Homoeopathic Medical College And Hospital Ramdayalu Nagar Muzaffarpur Bihar India 842002
Muzaffarpur
BIHAR 
8178340653

dr.neeharikasoni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee RBTS Govt Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L509||Urticaria, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Constitutional Homoeopathic Medicine  Selected medicine will be given on the basis of totality of symptoms and in consultation with posology 30, 200, 1m potency will be prescribed, the patient has to take medicine through mouth and follow up should be done at 15 days interval for minimum 6 follow up  
Comparator Agent  Not applicable  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient confirming with EB00 criteria of ICD 11.
Patient in age group of 15-60 years fulfilling the diagnostic criteria.
Both male and female.
Patients who give their written consent for participation.
 
 
ExclusionCriteria 
Details  Patient below the age of 15 years and above the age of 60 years.
Patient suffering from any co-morbidity.
Patient who do not give consent for homoeopathic participation.
Patient with complaint of Urticaria complicated with other dermatological affection.
Pregnant women and lactating mother.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
At the end of study we expect positive response of chosen homoeopathic medicine upon Urticaria   12 weeks - 15 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The study will encourage patients to take homoeopathic medicine in the cases of Urticaria.  12 weeks - 15 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 4 
Date of First Enrollment (India)   17/02/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Urticaria (’nettle rash’, ’hives’) presents with short-lived, itchy wheals which may be pale or pink in the centre, surrounded by a red flare. Individual lesions are round, oval or figurate and are often pruritic. It is a recurring skin disease. While treating cases which occurs frequently Master Hahnemann investigated about 12 years for the cause lurking behind recurring diseases and found Miasm to be the cause. According to Dr. Hahnemann, there are three primary causes of diseases: Psora, Syphilis and Sycosis. In any given patient, there could be the influence of one miasm, or any combination of them. An accurate miasmatic diagnosis depends on individual symptoms of the patient. These miasm develop due to many reasons in mental as well as physical plane. So, a instrument like anti-miasmatic medicines are required to root out these miasms.

Anti-miasmatic medicines help to clear up the suppressions (in relation to the past); clear up the presenting symptoms from their root or origin (in relation to the present); and clear up the susceptibility to get infection and there by strengthening the constitution (in relation to the prophylactic aspect of future).

At R.B.T.S. Government Homoeopathic Medical College and Hospital, a significant number of patients presents with urticaria. While various studies have explored the treatment of urticaria with homoeopathic medicines, there is a notable lack of research specifically focusing on the individualized constitutional approach in relation to miasmatic analysis. This gap in research has inspired me to pursue a study on this topic.

 
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