| CTRI Number |
CTRI/2022/05/042541 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in the management of Atopic Dermatitis in Paediatric age group |
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic Treatment in the Management of Atopic Dermatitis in Paediatrics Age Group- A Prospective Open Label Single Arm Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Organon of Medicine
S 35
Second Floor
36B
Knowledge PArk I
Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9971384376 |
| Fax |
|
| Email |
parul.dr222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parul |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Organon of Medicine
S 35
Second Floor
36B
Knowledge PArk I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9971384376 |
| Fax |
|
| Email |
parul.dr222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuroopam Swami |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic medical College & Hospital |
| Address |
Department of Organon of Medicine
S 35
Second Floor
36B
Knowledge PArk I
Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9868954687 |
| Fax |
|
| Email |
anuroopam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College Hospital |
| Address |
Room No G 22
Ground Floor
36B
Knowledge Park I
Greater Noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Parul |
Bakson Homoeopathic Medical College & Hospital |
Outpatient Department (OPD)
Room No G1
Ground Floor
36B Knowledge PArk I
Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9971384376
parul.dr222@gmail.com |
| Parul |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Outpatient Department
Room No 107 & 108
Ground Floor
Dr D P Rastogi Central Research Institute
Sector 24
Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9971384376
parul.dr222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homoeopathic Medical College & Hospital |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20||Atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Medicine will be prescribed after case taking.
Route of Administration- Oral
Globules Form. Pill size 30
Follow up every 15 days.
repetition will be done based on the follo up |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Age: 7 months - 14 years.
Sex: Either sex.
Diagnosed cases of Atopic Dermatitis.
Cases fulfilling William’s criteria for the diagnosis of Atopic Dermatitis.
|
|
| ExclusionCriteria |
| Details |
Use of any topical treatment for Atopic Dermatitis in past 15 days.
Evidence of skin conditions other than Atopic Dermatitis.
Oral or intravenous corticosteroids during last 1 month.
Cases associated with any systemic illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| it is expected that there will be changes in the POEM score in children treated with Homoeopathy in autiam |
12 months total
5 months enrollment
6 months treatment and follow up
1 month analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
20/05/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the Study is to assess the role of Homoeopathy in the management of Atopic dermatitis in paediatric age group. the scale used will be POEM scale secondary objective is to find out the most prominent miasm in atopic dermatitis. |