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CTRI Number  CTRI/2026/02/103738 [Registered on: 12/02/2026] Trial Registered Prospectively
Last Modified On: 12/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role Of Homoeopathic Medicine In The Management Of Chronic Urticaria 
Scientific Title of Study   A Clinical Study To Assess The Usefulness Of Causation In Homoeopathic Prescription In The Management Of Patients Suffering From Chronic Urticaria With Homoeopathic Remedies 
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 Amit Kumar 
Designation  Post Graduate Trainee 
Affiliation  State National Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1 Viraj Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9718688339  
Fax    
Email  amitkumar009718@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Om Prakash Singh 
Designation  Lecturer 
Affiliation  State National Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1 Viraj Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  7839318990  
Fax    
Email  dr.opsingh10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Kumar 
Designation  Post Graduate Trainee 
Affiliation  State National Homoeopathic Medical College and Hospital 
Address  Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1 Viraj Khand, Gomti Nagar, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9718688339  
Fax    
Email  amitkumar9718@gmail.com  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College And Hospital,1-Viraj Khand, Gomti Nagar, Lucknow-226010, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Dr Amit Kumar 
Address  Department of Organon Of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital,1-Viraj Khand, Gomti Nagar, Lucknow, Uttar Pradesh-226010 
Type of Sponsor  Other [Self] 
 
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 Amit Kumar  State National Homoeopathic Medical College And Hospital, Lucknow  OPD-2, Department of Organon of Medicine and Homoeopathic Philosophy, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH 
9718688339

amitkumar9718@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow  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 Homoeopathic Medicine  Patients qualifying inclusion and exclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization. Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses. Medicines will be given oral route in 30C or 200C or 1M or 10M potency as per requirement of the case. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on Urticaria Activity Score over 7 days and Chronic Urticaria Quality of Life Questionnaire at the end of 6 months  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients clinically diagnosed with chronic urticaria.
2.Participants of any gender, including male, female, and transgender individuals,
will be eligible for the study.
3.Patients belonging to the age group 18 years to 65 years.
4.Literate patients who can read English or Hindi will be included.
5.Illiterate patients will also be enrolled, and investigators will assist them in
completing the questionnaires or scales while ensuring adequate privacy.
6.Participants who will provide informed consent, comply with the study
protocols, and attend all scheduled follow-up visits. 
 
ExclusionCriteria 
Details  1.Patients suffering from severe systemic illnesses or any other life-threatening conditions.
2.Patients with a history of severe anaphylactic shock.
3.Pregnant and lactating women.
4.Patients who refuse to give informed consent and not willing to come for follow ups. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Individualized homoeopathic medicine based on causation in the management of Chronic Urticaria using Urticaria Activity Score over 7 days(UAS7) before and after the treatment  12 weeks to 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the changes in the quality of life of patients suffering from chronic urticaria using Chronic Urticaria Quality of Life Questionnaire(CU-Q2oL)  12 weeks to 24 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/02/2026 
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)  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  
Chronic urticaria is a common, relapsing dermatological condition characterized by the presence of recurrent wheals, itching, and occasional angioedema, significantly affecting the quality of life of patients. Identification of causative factors plays an important role in the homoeopathic system of medicine, as causation is considered a key element in individualizing the prescription and selecting the most appropriate remedy.
The present study is planned to assess the usefulness of causation in homoeopathic prescription in the management of patients suffering from chronic urticaria. Patients fulfilling the inclusion and exclusion criteria will be enrolled from the outpatient department. Detailed case taking will be carried out with special emphasis on eliciting causative factors, and individualized homoeopathic medicines will be prescribed accordingly.
The effectiveness of the treatment will be evaluated using the Urticaria Activity Score over 7 days (UAS7) to assess disease activity, along with the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) to evaluate the impact of the disease and its treatment on patients’ quality of life. Assessment will be done at baseline, after 3 months, and at 6 months to observe changes in the severity and frequency of urticarial symptoms as well as quality of life parameters. The findings of the study are expected to provide clinical evidence regarding the role of causation in homoeopathic prescribing for chronic urticaria.

 
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