| CTRI Number |
CTRI/2025/09/095374 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study effectiveness of individualised homoeopathic treatment in managing hypersensitivity in cases of urticaria. |
|
Scientific Title of Study
|
Prospective Single Arm Interventional Study To Assess Effectiveness Of Individualised Homoeopathic Treatment In Managing Hypersensitivity In Cases Of Urticaria. |
| 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 Chirag Tamboli |
| Designation |
Professor, Head Of Department, Homoeopathic Philosophy And Organon Of Medicine. |
| Affiliation |
Dr V. H. Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9428489176 |
| Fax |
|
| Email |
drchiragtamboli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Tamboli |
| Designation |
Professor, Head Of Department, Homoeopathic Philosophy And Organon Of Medicine. |
| Affiliation |
Dr V. H. Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9428489176 |
| Fax |
|
| Email |
drchiragtamboli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhruvi Shah |
| Designation |
PG Scholar |
| Affiliation |
Dr V. H. Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT
388001
India |
| Phone |
6351137497 |
| Fax |
|
| Email |
dhruvi180999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Dhruvi Shah |
| Address |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat |
| 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 Dhruvi Shah |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital |
Dr V H Dave Homoeopathic Medical College and Smt S I Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat
Anand
GUJARAT |
6351137497
dhruvi180999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-VHDHMC |
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 |
Individualised Homoeopathic Medicine |
The medicine will be selected from the totality of symptoms & compared with drug picture of homoeopathic medicines.
Repertorization will be done with the aid of synergy software. The individualized remedy shall be selected from drugs list obtained after.
The susceptibility will be judged from presentation of symptoms in the patient. The appropriate potency will be selected depending upon the susceptibility of the patient. The remedy will be changed or repeated as per the requirement of the case. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases of Urticaria irrespective of gender and 5-80 years of age.
Pre diagnosed cases already on allopathic treatment, but now switched to Homeopathic treatment.
Patients willing to give consent for the study.
Children from age 5 to 18 years willing to give assent and their parent’s will for consent.
|
|
| ExclusionCriteria |
| Details |
Cases with severe systemic disease and cannot be managed at opd level.
Pregnant females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved patient reported quality of life
Changes in quality of life score [CU-Q2oL Score]
|
Every follow up
And at the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in itching,burning and wheals.
Decreased redness and discomfort. |
At every follow up. |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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 3 |
|
Date of First Enrollment (India)
|
05/10/2025 |
| 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="0"
Months="9"
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
|
Urticaria is a common dermatological disorder with considerable global and national health impact, often associated with angioedema and recurrent episodes affecting quality of life. Despite the availability of conventional therapies, management remains suboptimal, especially in regions like India, due to limited diagnostic facilities, high costs, and inadequate control of relapses. Homeopathy approaches the condition from a holistic perspective, emphasizing the disturbance of vital force, susceptibility, and idiosyncrasy, which influence an individual’s reaction to external and internal stimuli. Environmental stressors, psychosomatic factors, and lifestyle habits further contribute to hypersensitivity responses leading to urticaria. In clinical evaluation, the CU-Q2OL scoring system provides a structured means to assess symptom intensity and quality of life before and after treatment, ensuring objective monitoring. By integrating clinical scoring with individualized homeopathic intervention, a more comprehensive and sustainable therapeutic outcome can be achieved, addressing both the physical manifestations and underlying psychosomatic dimensions. |