| 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
|
|
|
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
|
|
|
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. |