| 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
|
|
|
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
|
|
|
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.
|