| CTRI Number |
CTRI/2025/09/095441 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Experimental study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see which works better for chronic hives : Histaminum or personalized homoeopathic medicine |
|
Scientific Title of Study
|
An experimental clinical study to Assess the Effect of HISTAMINUM vs Constitutional Medicine in Cases of Chronic Urticaria Assessed with UAS7 Score |
| 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 Gayatri Laxmanbhai Parmar |
| Designation |
Pg scholar |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
Plot no 16 madhuvan park society madhapar chowk Rajkot Gujarat India 360006
Room no 1 medicine department Gondal road,near makkam chowk behind jaynath complex Rajkot Gujarat India 360002
Rajkot
GUJARAT
360006
India |
| Phone |
8980010086 |
| Fax |
None |
| Email |
drgayatrijjadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vani oza |
| Designation |
Professor, HOD |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
14 samanvay society raiya road near alap green city Rajkot Gujarat India 360007
Gondal road near makkam chowk behind jaynath complex Rajkot Gujarat India 360002
Rajkot
GUJARAT
360007
India |
| Phone |
9428052673 |
| Fax |
None |
| Email |
Vanioza8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGayatri Laxmanbhai Parmar |
| Designation |
PG scholar |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
Plot no 16,madhuvan park society madhapar chowk Rajkot Gujarat India 360006
Gondal road near makkam chowk behind jaynath complex Rajkot Gujarat India 360002
Rajkot
GUJARAT
360006
India |
| Phone |
8980010086 |
| Fax |
None |
| Email |
drgayatrijjadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot homoeopathic medical college |
|
|
Primary Sponsor
|
| Name |
Sainath hospital |
| Address |
Gondal road,near makkam chowk, behind jaynath complex, Rajkot Gujarat India |
| 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 Gayatri Laxmanbhai parmar |
Sainath homeopathic hospital |
Room no 101,medicine department,Gondal road, near makkam chowk, behind jaynath complex, Rajkot Gujarat India 360002
Rajkot
GUJARAT |
89800 10086
drgayatrijjadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for human research-Rajkot homoeopathic medical college [RHMC],Parul University, Gujarat |
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 |
An experimental clinical study to Assess the Effect of HISTAMINUM vs Constitutional Medicine in Cases of Chronic Urticaria Assessed with UAS7 Score |
To check the effect of new homoeopathy medicine histaminum in Cases of Chronic Urticaria |
| Intervention |
Dose as per patients susceptibility mostly 30 0r 200 potency |
Frequency as per disease condition potency selection is 30 or 200 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adult age clinically Diagnosed with chronic urticaria lasting 6 weeks or more willing to adhere to regular follow-up and study protocol not currently undergoing any other treatment for urticaria |
|
| ExclusionCriteria |
| Details |
Patients with acute urticaria duration less than 6 weeks individuals with autoimmune diseases or immunodeficiency disorders Patients under immunosuppressive medication Pregnant or breastfeeding women, unsupportive or Unwilling participants |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients might be relieved from histaminum medication |
1 week to 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient may feel better by histaminum medicine |
Within 1 to 2 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="30" |
|
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
|
Chronic urticaria is persistent skin disorder marked by recurrent wheals ,itching and angioedema for more than six weeks. conventional antihistamines often given only temporary relief. Homoeopathy offers both fixed remedies and individualized treatment option. This experimental clinical study aims to compare the effect of HISTAMINUM with individualized constitutional homoeopathic medicines in patients with chronic urticaria. Assessment of improvement will be done using the UAS7score. This study is designed to evaluate which approach fixed or individualized provides greater symptoms control and improvement in quality of life. The results may help establish evidence-based guidance for homoeopathic management of chronic urticaria. |