| CTRI Number |
CTRI/2025/02/080069 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Treatment of Urticaria |
|
Scientific Title of Study
|
A clinical study on the efficacy of Individualized constitutional medicine in cases of Urticaria along with miasmatic study |
| 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 Neeharika Soni |
| Designation |
PG Scholar Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Department of Organon of Medicine and Homoeopathic Philosophy |
| Address |
Room Number 08 Academic Block RBTS Govt Homoeopathic Medical College And Hospital
RDS Chowk Ramdayalu Nagar
Muzaffarpur
Muzaffarpur BIHAR 842002 India |
| Phone |
8178340653 |
| Fax |
|
| Email |
dr.neeharikasoni@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neeharika Soni |
| Designation |
PG Scholar Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Department of Organon of Medicine and Homoeopathic Philosophy |
| Address |
Room Number 08 Academic Block RBTS Govt Homoeopathic Medical College And Hospital
RDS Chowk Ramdayalu Nagar
Muzaffarpur
Muzaffarpur BIHAR 842002 India |
| Phone |
8178340653 |
| Fax |
|
| Email |
dr.neeharikasoni@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashi Bhushan Singh |
| Designation |
Associate Professor Department of Gynaecology and Obstetrics |
| Affiliation |
RBTS Govt Homoeopathic Medical College And Hospital |
| Address |
Room Number 08 Academic Block RBTS Govt Homoeopathic Medical College And Hospital
RDS Chowk Ramdayalu Nagar
Muzaffarpur
Muzaffarpur BIHAR 842002 India |
| Phone |
7739645479 |
| Fax |
|
| Email |
singh.sb20@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic Medical College and Hospital Ramdayalu Nagar Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
RDS Chowk Ramdayalu Nagar Muzaffarpur Bihar India 842002 |
| 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 Neeharika Soni |
RBTS Govt Homoeopathic Medical College and Hospital |
OPD 1 Medicine OPD 5 Organon Dept OPD 6 Materia Dept OPD 7 Repertory
RBTS Govt Homoeopathic Medical College And Hospital
Ramdayalu Nagar
Muzaffarpur
Bihar
India 842002 Muzaffarpur BIHAR |
8178340653
dr.neeharikasoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RBTS Govt Homoeopathic Medical College and Hospital |
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 Constitutional Homoeopathic Medicine |
Selected medicine will be given on the basis of totality of symptoms and in consultation with posology 30, 200, 1m potency will be prescribed, the patient has to take medicine through mouth and follow up should be done at 15 days interval for minimum 6 follow up |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient confirming with EB00 criteria of ICD 11.
Patient in age group of 15-60 years fulfilling the diagnostic criteria.
Both male and female.
Patients who give their written consent for participation.
|
|
| ExclusionCriteria |
| Details |
Patient below the age of 15 years and above the age of 60 years.
Patient suffering from any co-morbidity.
Patient who do not give consent for homoeopathic participation.
Patient with complaint of Urticaria complicated with other dermatological affection.
Pregnant women and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of study we expect positive response of chosen homoeopathic medicine upon Urticaria |
12 weeks - 15 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will encourage patients to take homoeopathic medicine in the cases of Urticaria. |
12 weeks - 15 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 (’nettle rash’, ’hives’) presents with
short-lived, itchy wheals which may be pale or pink in the centre, surrounded
by a red flare. Individual lesions are round, oval or figurate
and are often pruritic. It is a recurring skin disease. While treating cases which occurs frequently Master Hahnemann investigated about 12 years for the cause lurking behind recurring diseases and found Miasm to be the cause. According to Dr. Hahnemann, there are three primary causes of diseases: Psora, Syphilis and Sycosis. In any given patient, there could be the influence of one miasm, or any combination of them. An accurate miasmatic diagnosis depends on individual symptoms of the patient. These miasm develop due to many reasons in mental as well as physical plane. So, a instrument like anti-miasmatic medicines are required to root out these miasms. Anti-miasmatic medicines help to clear up the suppressions (in relation to the past); clear up the presenting symptoms from their root or origin (in relation to the present); and clear up the susceptibility to get infection and there by strengthening the constitution (in relation to the prophylactic aspect of future). At R.B.T.S. Government Homoeopathic Medical College and Hospital, a significant number of patients presents with urticaria. While various studies have explored the treatment of urticaria with homoeopathic medicines, there is a notable lack of research specifically focusing on the individualized constitutional approach in relation to miasmatic analysis. This gap in research has inspired me to pursue a study on this topic. |