| CTRI Number |
CTRI/2025/08/092363 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of individualized homoeopathic medicine in the cases of Chronic Urticaria using CU-Q2OL QUESTIONNAIRE |
|
Scientific Title of Study
|
An Interventional Study to Assess the Role of Individualized Homoeopathic Medicine in the Cases of Chronic Urticaria Using CU-Q2OL Questionnaire |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pushpanjali Daswani |
| Designation |
Post graduate resident |
| Affiliation |
swasthya kalyan homeopathic medical college jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre 10 A Sitapura Industrial Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
8441041036 |
| Fax |
|
| Email |
pushpanjalidaswani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Thebar |
| Designation |
HOD of Department of pratice of medicine |
| Affiliation |
swasthya kalyan homeopathic medical college jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10-A Sitapura Industrial Area, Tonk Road, Goner Road,Sitapura Industrial Area, Sitapura , Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829391362 |
| Fax |
|
| Email |
thebarjagdish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagdish Thebar |
| Designation |
HOD of Department of pratice of medicine |
| Affiliation |
swasthya kalyan homeopathic medical college jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10-A Sitapura Industrial Area, Tonk Road, Goner Road,Sitapura Industrial Area, Sitapura , Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829391362 |
| Fax |
|
| Email |
thebarjagdish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre 10 A Sitapura Industrial Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
swasthya kalyan Homoeopathic Medical College And Research Centre |
| Address |
OPD Medicine 1 and 2 room number 29 and 30 and OPD Speciality room number 26 Swasthya Kalyan Homoeopathic Medical College and Research Centre 10 A Sitapura Industrial Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| pushpanjali daswani |
swasthya kalyan |
swasthya kalyan Homeopathic Medical College And Research Centre Jaipur RAJASTHAN
Jaipur
RAJASTHAN |
8441041036
pushpanjalidaswani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKHMCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, (2) ICD-10 Condition: L502||Urticaria due to cold and heat, (3) ICD-10 Condition: L501||Idiopathic urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines |
Dose and Potency according to susceptibility of patient and need of the case
Globule number 30
Route of drug administration Sublingual
for 3 months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of chronic urticaria, based on EAACI/GA²LEN/EDF/WAO consensus guidelines or ICD-11 clinical guidance —including both chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)—presenting with recurrent wheals angioedema or both persisting for six weeks or more.
Patients aged 18 and above.
Both the sexes.
Patients willing to participate and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients unable or unwilling to provide written informed consent.
Patients with other medical conditions or those receiving systemic corticosteroids immunosuppressive therapy or alternative treatments that could affect the outcome of the study will be excluded.
Patients with other dermatological or systemic conditions that can mimic chronic urticaria—such as urticarial vasculitis bullous pemphigoid mastocytosis (e.g. urticaria pigmentosa) cutaneous lupus erythematosus papular urticaria drug-induced dermatoses or napkin-area infection Schnitzler’s Syndrome Gleich’s Syndrome or Well’s Syndrome (e.g. Eosinophilic Cellulitis).
Patients with systemic autoinflammatory disorders such as Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) Muckle-Wells Syndrome (MWS) and Neonatal-Onset Multisystem Inflammatory Disease (NOMID).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study, it is expected that individualized Homoeopathic medicine will play an effective role in the treatment of chronic urticaria, as measured by the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL).
• It is expected that analysis of the study data will identify the most commonly prescribed Homoeopathic medicine in cases of chronic urticaria.
|
At Baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
29/08/2025 |
| 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="1"
Months="0"
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
|
This study is a interventional and single arm to see the role of individualized homoeopathic medicine in the cases of chronic urticaria . the study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur . the primary outcome measure assess through CU-Q2OL QUESTINNAIRE ( chronic urticaria quality of life questionnaire) , regular follow-up assessment . it will be conducted for 1 year. the objectives are to assess the changes after homoeopathic intervention to the cases of chronic urticaria . and see the what commonly prescribed homoeopathic medicine for the treatment of chronic urticaria over the study period. |