| CTRI Number |
CTRI/2025/09/094135 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Role of homeopathic medicine in managing Chronic urticaria Using Urticaria Control Test and Absolute Eosinophils Count . |
|
Scientific Title of Study
|
Scope of indicated homeopathic medicine in management of cases of chronic urticaria using urticaria control test and absolute eosinophils count:An uncontrolled experimental 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 Divyani Ganesh Hedaoo |
| Designation |
MD-Part 1 |
| Affiliation |
Dr.M.L. Dhawle Memorial Trust Homeopathic medical college palghar |
| Address |
At post khapa tah saoner dist -nagpur
Dr.M.L.Dhawle Memorial trust Hospital ,Palghar
boisar road ,opposite S.T.workshop ,palghar taluka industrial co-operative estate palghar ,maharashtra 401404
Palghar
MAHARASHTRA
441101
India |
| Phone |
9579213717 |
| Fax |
|
| Email |
divyanihedaoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshala sarvagoad |
| Designation |
Reader |
| Affiliation |
Dr.m.l.dhawle homeopathic medical college palghar |
| Address |
At Dr.M.L.dhawle Memorial trust hospital palghar
Boisar road ,S.T. workshop ,Palghar taluka co operative society estate palghar maharashtra 401404
At Dr.M.L.dhawle Memorial trust hospital palghar
Boisar road ,S.T. workshop ,Palghar taluka co operative society estate palghar maharashtra 401404
Mumbai (Suburban)
MAHARASHTRA
401404.
India |
| Phone |
8108777599 |
| Fax |
|
| Email |
Harshsarvagodr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshala sarvagoad |
| Designation |
Reader |
| Affiliation |
Dr.m.l.dhawle homeopathic medical college palghar |
| Address |
At Dr.M.L.dhawle Memorial trust hospital
dist -Palghar ,
boisar road , Plghar taluka industrial co -operative Estate ,palghar ,Maharashtra
At Dr.M.L.dhawle Memorial trust hospital
dist -Palghar ,
boisar road , Plghar taluka industrial co -operative Estate ,palghar ,Maharashtra
Mumbai (Suburban)
MAHARASHTRA
401404.
India |
| Phone |
8108777599 |
| Fax |
|
| Email |
Harshsarvagodr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr ML Dhawale Memorial Homoeopathic Institute, Palghar |
|
|
Primary Sponsor
|
| Name |
MLDhawale Memorial Homoeopathic Institute |
| Address |
M.L.Dhawale Memorial Homoeopathic Institute, Near ST workshop ,Boisar palghar road ,palghar taluka industrial co operative estate palghar pin-code -401404 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Harshala sarvagod |
Dr ML Dhawale homoeopathic institute |
307, 2nd floor, dr.m.l.dhawale memorial homeopathic institute ,palghar boisar road opp.S.T. workshop road ,Palghar -401404
Palghar
MAHARASHTRA |
8108777599
harshalasarvagodr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. M.L. Dhawale Memorial Homeopathic Institute Palghar |
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 |
Indicated homoeopathic constitutional medicine |
Indicated homoeopathic constitutional medicine will be given as required daily or weekly for 6 months of duration. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.All gender
2.Age above 18 years
3.Diagnosed cases of Chronic urticaria AS per standard clinical diagnostic Criteria
4.Urticaria cases with angioedema
5.Cases of Chronic urticaria with raised Absolute Eosinophil count.
6.Patients who are willing to taper down and gradually stop the Antihistaminic.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant females
2.Patient who are under the Steroidal treatment and Immuno- modulators for chronic urticaria.
3.Patient also suffering with other skin disorders which presents with itching as Subjective distress.
4.Urticaria cases with angioedema but having Respiratory distress.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in severity of subjective distress, and quality of life and to achieve control in chronic urticaria assessed with urticaria control test kduring 6 months of homeopathic treatment. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the improvement in absolute eosinophilic count in cases of chronic urticaria during the 6 months of homoeopathic treatment |
6 months |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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 2 |
|
Date of First Enrollment (India)
|
14/09/2025 |
| 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="0"
Months="6"
Days="6" |
|
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
|
Scope of indicated homeopathic medicines in the management of Chronic Urticaria assessed by Urticaria Control Test and Absolute Eosinophils Count: An uncontrolled experimental study.To assess the improvement in severity of subjective distress, and quality of life and to achieve control in chronic urticaria assessed with urticaria control test during 6 months of homeopathic treatment.
|