| CTRI Number |
CTRI/2025/03/082771 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to assess the usefulness of homoeopathic medicines in cases of chronic urticaria |
|
Scientific Title of Study
|
A randomized open label clinical trial to compare the effectiveness of antipyrinum with constitutional homoeopathic medicines in the cases of chronic 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 Arun Nishad |
| Designation |
PG SCHOLAR |
| Affiliation |
Dr MPK Homeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica Dr MPK Homeopathic Medical College Hospital and Research Center, A Constituent College of Homeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
8824732680 |
| Fax |
|
| Email |
arunnishad3324@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanija Sharma |
| Designation |
Associate Professor and Head of the Department of Materia Medica |
| Affiliation |
Dr MPK Homeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica Dr MPK Homeopathic Medical College Hospital and Research Center, A Constituent College of Homeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9680438770 |
| Fax |
|
| Email |
drvanijasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Nishad |
| Designation |
PG SCHOLAR |
| Affiliation |
Dr MPK Homeopathic Medical College Hospital and Research Centre |
| Address |
Dr MPK Homeopathic Medical College Hospital and Research Center, A Constituent College of Homeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
8824732680 |
| Fax |
|
| Email |
arunnishad3324@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Materia Medica Dr Girendra Pal Homeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital and Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homeopathic Medical College Hospital and Research Centre |
| Address |
Saipura Sanganer Jaipur, pincode 302029 |
| Type of Sponsor |
Private 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 Arun Nishad |
Dr Girendra Pal Homeopathic Hospital and Research Centre |
Department of Materia Medica Room No. 4, Unit 1 Dr.MPK Homeopathic Medical College Hospital and Research Centre Homeopathy University, 10, 11, 12, Hahnemann Marg, Diggi Malpura Road, Saipura Sanganer, Jaipur, Rajasthan 302029
Jaipur
RAJASTHAN |
8824732680
arunnishad3324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antipyrinum |
Medicine shall be given orally in any potency 30c, 200c, 1M, 10M , 5OM , CM as per the case and Hahnemannian guidelines of organon of medicine in the form of globules of 40 numbers, dose and repetition as per need of the case reassessment at the end of 3 months |
| Comparator Agent |
CONSTITUTIONAL HOMOEOPATHIC MEDICINES |
Homoeopathic medicine shall be given orally in any potency 6c, 30, 200c, 1M, 10M, 50M, and CM as per the case and Hahnemannian guidelines of organon of medicine in the form of globules of 40 numbers, dose and repetition as per need of the case reassessment at the end of 3 months
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient has itchy erythematous wheals eruption appear on skin with or without angioedema subsiding automatically or maximum within 24 hours
Age group 19 years to 65 years
Patient of both the gender
Urticaria for more than 6 weeks would be taken
Patient who gave consent for the study
|
|
| ExclusionCriteria |
| Details |
Cases with any other uncontrolled systemic pathological conditions with active conventional treatment
Cases with any other immunologically compromised patients
Patient pursuing other pharmacological treatment or intervention except anti-allergic and anti-histamine drugs to control acute exacerbations
Female patient who wants to conceive are pregnant and lactating
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained pre- and post-treatment on the UAS-7 scale. |
Pre score will be taken at the baseline of the treatment and post score will be assessed at the end of 12 weeks using UAS-7 scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The constitutional homeopathic medicines & Antipyrinum will be effective in managing the cases of chronic urticaria
It is expected that constitutional homeopathic medicines & Antipyrinum will be improve intensity & frequency in cases of chronic urticaria |
12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
29/03/2025 |
| 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 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
|
AIM To
compare the effectiveness of antipyrinum
with constitutional homoeopathic
medicines in the cases of chronic urticaria Objectives To assess the
effectiveness of homoeopathic medicine antipyrinum in the
cases of chronic urticaria through pre and post UAS-7 SCORE Compare the results
of constitutional homoeopathic medicines and antipyrinum in
the management of chronic urticaria cases assessed through pre and post-UAS-7
SCORE
|