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CTRI Number  CTRI/2024/09/073886 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Therapeutic utility of Kents Repertory in the treatment of chronic urticaria among the patients between the age group of 20 to 40 years.  
Scientific Title of Study   A Single group, Pre-Post Study to assess the therapeutic utility of Kents Repertory in the treatment of Chronic urticaria among the Patients between the age group of 20 to 40 years 
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 Anamika Das 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. B.N. Chakraborty Sarani, Doomurjola, Howrah

Haora
WEST BENGAL
711104
India 
Phone  8777488494  
Fax    
Email  1994anamikadas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradip Kumar Bairi 
Designation  Professor and HOD of Department of Repertory 
Affiliation  Mahesh Bhattacharyya Homeopathic Medical College and Hospital 
Address  Dr. B.N. Chakraborty Sarani, Doomurjola, Howrah, Room No- 11

Haora
WEST BENGAL
711104
India 
Phone  943312293  
Fax    
Email  drpkbairi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradip Kumar Bairi 
Designation  Professor and HOD of Department of Repertory 
Affiliation  Mahesh Bhattacharyya Homeopathic Medical College and Hospital 
Address  Dr. B.N. Chakraborty Sarani, Doomurjola, Howrah, Room No-11

Haora
WEST BENGAL
711104
India 
Phone  943312293  
Fax    
Email  drpkbairi@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Address- Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal, India  
 
Primary Sponsor
Modification(s)  
Name  Dr Anamika Das 
Address  Dr. B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, India 
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 Anamika Das  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Dr. B.N. Chakraborty Sarani, Doomurjola, Howrah-711104,Department of Repertory, Room No-11
Haora
WEST BENGAL 
8777488494

1994anamikadas@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L501||Idiopathic urticaria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  All Patients enrolled in the study will be receiving homoeopathic medicine on the basis of individualization at frequency of one month of interval for three months. Both Centesimal and Fifty Millesimal potencies will be used. All medicine procured will be GMP certified. Along with medicines, the patients will receive dietary advice. Diet management according to individual patients requirements. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients presenting with clinical features of chronic spontaneous urticaria like wheals, nettle rash and itching.
Patients between the age group between 20-40 years will be included.
Patient who are willing to give consent for the study.
Patient not under any homoeopathic treatment for last two weeks 
 
ExclusionCriteria 
Details  Patients unwilling to participate in the study and unwilling to sign the informed consent.
Patients with underlying malignancy or any such condition which needs emergency medical intervention.
Patients who are undergoing homoeopathic treatment for any chronic disease for last 6 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Disease severity will be measured with Urticaria Control Test-7(according to; author of scale, that scoring instructions of UCT7 are same as for UCT) where 0 the minimum and maximum UCT score [40] are 0 and 16 (developed by Marcus Maurer et al), with 16 points indicating complete disease control.  Each patient will get follow-up for at least 3 months at the interval of 1 months 
 
Secondary Outcome  
Outcome  TimePoints 
secondary outcome will be measured using CU Q20l Health-related QoL of CU patients will be calculated by CU QoL Questionnaire.  each patient will get follow up for at least 3 months at the interval of 1 month. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   23/09/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
INTRODUCTION
Chronic urticaria (CU) is the recurrence of wheals, angioedema, or both related to an inflammatory rection with unknown aetiology, lasting 6 weeks due to a variety of known and unknown reasons. The condition is characterized by a central swelling surrounded by an itchy erythema, whereas angioedema is linked with severe swelling of the lower dermis and subcutaneous tissue, with the occasional involvement of the mucous membranes of the lips and tongue. Chronic urticaria is split into two types: chronic spontaneous urticaria (CSU); that related with either idiopathic or autoimmune cause and chronic inducible urticaria (CIU); that due to physical factors. The lack of a distinct identifiable trigger cause subjugated with non-specific course and symptoms might make treating the disorder difficult. Previous research has shown that the prevalence is higher in the 20 – 40year age range, but it can occur in any age group [3]. Physicians are concerned about CSU because it not only impacts physical health but also impairs quality of life due to variables such as subcutaneous oedema, itching, and pain [4]. Sleep deprivation has been connected to the emergence of itching and hives [5-7], suggesting that mental health might be damaged to some extent. According to studies, delays in diagnosis are usually related with such diseases, lengthening the period of suffering for patients. The average time to diagnosis in Canada was 24 months, 3 years in Central/South America, and 2-4 years in Western Europe [8,9]. This causes severe frustration in up to 67 percent of patients, not to mention the excessive use of medical resources for no additional benefit, which has a significant impact on quality of life [10,11]. Furthermore, studies have shown that throughout the phase of following SARS-CoV-2 waves, hospital-based urticaria centers of reference and excellence (UCAREs) experienced numerous obstacles, resulting in large delays in the treatment of chronic urticaria patients [12]. Homoeopathy has faced a high demand among the patients suffering from various dermatological illnesses in recent years [13]. As there are no study conducted in this part of the country on
chronic urticaria so considering the scenario in this study we will try to access the efficacy of homoeopathic medicine to treat the patients suffering from CU and to determine the changes it can cause to upgrade the quality of life among the patients with the help of Chronic Urticaria Quality of Life Questionnaire (CU-Q2O)..The main goal of treatment of CU are to relief the systemic symptoms with improvement of physical and mental functions. Modern medications have limited scope to treat CU.
In Homoeopathy the innermost core of philosophy allows treating the patient on the idea of individualization. Homoeopathy acts both as a preventive moreover as a curative mode of treatment because it relies on the totality of presenting symptoms regardless of the name of disease. The totality includes subjective and objective understanding about the disease state where the underlying cause and also the individual’s susceptibility are being addresses.
JUSTIFICATION OF STUDY-
With such huge number and impact on quality of life of an individual, recurrent acute episodes of chronic urticaria cases are become challenge for health care system of any nation and their long-term solution offers will help the individual and society at large. As mentioned, the conventional system has very little to offer and even those modest benefits are to be evaluated over the possible harms. The homoeopathic medicines based on individualization have a great scope in treating these cases and in addition they also improve the general health and well-being of the person in a gentle way. However, there is some of literature to support this. The earlier works [14,15,16] on the subject are either not based on concept of individualization and single medicine or lack quality and use of validated scale. Hence, this study is undertaken.
RESEARCH QUESTION: - Are Individualized homoeopathic medicines effective in reducing the severity and improvement of quality of life of patients suffering from chronic urticaria using Kent’s repertory?
 HYPOTHESIS:
Null Hypothesis (H0):- There is no significant role of individualized homoeopathic medicines in reducing the severity in patients with chronic urticaria.
Alternative Hypothesis (HA):- Individualized homoeopathic medicines have significant role in reducing the severity in patients with chronic urticaria.
 
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