| CTRI Number |
CTRI/2026/03/106206 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Atopic dermatitis and paediatrics in homoeopathy |
|
Scientific Title of Study
|
To assess the effectiveness of constitutional homoeopathic treatment in case of atopic dermatitis in paediatric age group:a pre test post test interventional 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 Rani Jaiswal |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy delhi |
| Address |
National Institute of Homoeopathy sector A-5 Choudhary ramdev chowk narela Delhi India
North West
DELHI
110040
India |
| Phone |
7691910696 |
| Fax |
|
| Email |
ranijaiswal0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vignesh kumar S |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Homoeopathy delhi |
| Address |
National Institute of Homoeopathy sector A-5 Choudhary ramdev chowk narela Delhi
North West
DELHI
110040
India |
| Phone |
8754779061 |
| Fax |
|
| Email |
lancevignesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh kumar S |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Homoeopathy delhi |
| Address |
National Institute of Homoeopathy sector A-5 Choudhary ramdev chowk narela Delhi India
North West
DELHI
110040
India |
| Phone |
8754779061 |
| Fax |
|
| Email |
lancevignesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy delhi |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy sector A-5 Choudhary ramdev chowk narela Delhi |
| Address |
Sector A-5 Choudhary ramdev chowk narela Delhi 110040 |
| 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 Vignesh kumar S |
National Institute of Homoeopathy |
Sector A-5 Choudhary ramdev chowk narela Delhi
North West
DELHI |
8754779061
lancevignesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
constitutional homoeopathic medicine |
Administering indicated homoeopathic medicine as appropriate to the case for a period of 3 months, medicine will be dispensed in centesimal potency and will be administered orally; dosage and repetition will depend upon the individual requirement of the
case. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant fulfilling Hanifin and Rajka diagnostic criteria.
2. Participants belonging to mild, moderate and severe category of SCORAD Index.
3. Participants parents willing to give written informed consent and the patients willing to give verbal assent (children aged between 7-12 years) and or written assent (children aged between 12-17years).
4. Participants in the age group of 4-17 years.
5. Participants of all genders.
6. Participant already undergoing oral/topical conventional therapy for atopic dermatitis may be recruited after a washout period of 15 days. |
|
| ExclusionCriteria |
| Details |
1. Complicated cases of atopic dermatitis like severe secondary infections.
2. Critically ill patient, immune-compromised patient.
3. Patient suffering from any other uncontrolled systemic diseases.
4. Diagnosed cases of unstable mental or psychiatric illness.
5. Patient having any substance abuse. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scoring for Atopic Dermatitis (SCORAD) index |
Accessed at baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Children’s Dermatological Life Quality Index (CDLQI) |
Accessed at baseline and after 3 months. |
| MODIFIED NARANJO CRITERIA FOR HOMOEOPATHY (MONARCH) |
Measured after 3 months of follow up |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
25/03/2026 |
| 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="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
|
Atopic dermatitis (ICD-10 L20.9) is a chronic, non-communicable
recurring skin disorder seen more commonly in infants and children but can occur in any
age group. Atopic dermatitis being a chronic disease, affects the quality of life of the
patient as well as the family. Although homoeopathy offers holistic care this study aims to see the utility of constitutional
homoeopathic treatment in the management of atopic dermatitis. After extensive research,
we could find the studies in the field of constitutional homoeopathic treatment in the case of
atopic dermatitis in paediatric age group are lacking and unexplored. Atopic dermatitis often leading to significant morbidity adversely affecting a child’s quality
of life and daily functioning. Constitutional homeopathic treatment may offer a safer, less
invasive alternative, with a focus on tailoring remedies to the unique symptoms and
constitution of each child. This personalized approach is essential in Paediatrics, where
children may respond differently to treatments compared to adults. The enrollment will be done as per inclusion criteria given. The patient will be given individualized homoeopathic medicine based on symptom similarity. Primary outcome will be accessed by SCORAD index at baseline and after 3 months of follow up, secondary outcome will be accessed by CDLQI at baseline and after 3 months of follow up and MONARCH criteria after 3 months of follow up. Duration of intervention 3 months. |