| CTRI Number |
CTRI/2025/08/092542 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Application of Homoeopathic Repertory in Chronic Urticaria assessed using Urticaria Control Test. |
|
Scientific Title of Study
|
Application of Synthesis Repertory (Radar Opus 3.3 - Synthesis Treasure Edition) in treatment of chronic urticaria assessed by Urticaria Control Test - An Experimental Uncontrolled 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 Yogini Deepak Shirode |
| Designation |
Post Graduate Student |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar |
| Address |
316 Department of Repertory, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar - Boisar Road, Opp. S. T. Workshop, Palghar- 401 404, India.
Thane
Maharashtra
401404
India
Thane MAHARASHTRA 401404 India |
| Phone |
9665288731 |
| Fax |
|
| Email |
yogini.shirode@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nikunj Jani |
| Designation |
Associate Professor And Head Of Department |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar |
| Address |
315 Department of Repertory, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar - Boisar Road, Opp. S. T. Workshop, Palghar- 401 404, India.
Thane
Maharashtra
401404
India
Thane MAHARASHTRA 401404 India |
| Phone |
9323180460 |
| Fax |
|
| Email |
drnikunj@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nikunj Jani |
| Designation |
Associate Professor And Head Of Department |
| Affiliation |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar |
| Address |
315 Department of Repertory, Dr M L Dhawale Memorial Homoeopathic Institute, Palghar - Boisar Road, Opp. S. T. Workshop, Palghar- 401 404, India.
Thane
Maharashtra
401404
India
Thane MAHARASHTRA 401404 India |
| Phone |
9323180460 |
| Fax |
|
| Email |
drnikunj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeopathic Institute , Palghar - Boisar Road , Opp. S.T. Workshop , Palghar - 401404, Dist. Palghar, Maharshtra, India. |
|
|
Primary Sponsor
|
| Name |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute Palghar Palghar- Boisar Road, Opp. S. T. Workshop, Dist. Palghar, Maharashtra, India, Thane, Maharashtra, 401404 |
| 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 Anoop Nigwekar |
Dr. M. L. Dhawale Memorial Homoeopathic Institute Palghar |
315, Department of Repertory, 2nd floor, Dr. M. L. Dhawale Memorial Homoeopathic Institute Palghar Palghar- Boisar Road, Opp. S. T. Workshop, Dist. Palghar, Maharashtra, India, Thane, Maharashtra, 401404. Thane MAHARASHTRA |
9324933032
anoopnigwekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. M. L. Dhawale Memorial Homoeopathic Institute Palghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L50||Urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated Homoeopathic Medicine |
Indicated Medicine- Acute/Chronic/Intercurrent, Dose-30/200/1M/10M Potency As Per Indication, Frequency weekly dose , Route Of Administration-Oral,Duration-6Month. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are diagnosed with chronic urticaria.
Patients of both sexes.
18 year and above age group.
Patients who are taking anti-histaminic drugs for urticaria.
|
|
| ExclusionCriteria |
| Details |
Patients who are taking immunomodulators for urticaria.
Other comorbidities like DM , HTN , Hypothyroidism.
Drug hypersensitivity reactions such as lepra reaction.
Patient having presentation of angioedema with respiratory distress. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the action of indicated homoeopathic medicine as per Synthesis
Repertory in treatment of Chronic Urticaria assessed through Urticaria
Control Test.
|
0 month i.e. before treatment , after 3 months of treatment and after 6 months of treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To enlist common rubrics & prescribed homoeopathic medicines through
clinical cases of Chronic Urticaria. |
after 6 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" 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
|
Chronic Urticaria is a mast cell-driven disease that is defined as the occurrence of wheals/hives or both twice in a week for more than 6 weeks due to known or unknown causes. It appears as raised erythematous skin lesions that are pruritic, evascent and worsened up by scratching. It affects 15-20% of the population once or more during a lifetime. In around 30% patients of urticaria, attacks often recur for months or years. As Urticaria comes under hypersensitive reaction of the skin, there is recurrence of symptoms within individuals. Here we have to assess recurrence of symptoms through its intensity and frequency. We can check it through the Urticaria Control Test scale. The Urticaria Control Test is a questionnaire designed to determine if chronic urticaria is controlled or not and to aid therapeutic decision-making. Homoeopathy is useful in the treatment of Chronic Urticaria and hence I want to take this topic for study to understand the improvement in Chronic Urticaria on the Urticaria Control Test scale through Synthesis Repertory. In the end we will understand the usefulness of Synthesis Repertory in Chronic Urticaria. |