| CTRI Number |
CTRI/2025/12/099773 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in LM Potency and Atopic Dermatitis(AD) in Paediatric age group. |
|
Scientific Title of Study
|
ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES
USING 50 MILLESIMAL POTENCY IN REDUCING ABSOLUTE EOSINOPHIL COUNT (AEC)
IN PAEDIATRIC ATOPIC DERMATITIS: A SINGLE ARM PRE- POST ASSESMENT
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 Amiya Dash |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD number 32 Department of Paediatrics National Institute of Homoeopathy Block GE Sector 3 Kolkata
North Twentyfour Parganas
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9938995002 |
| Fax |
|
| Email |
homeoamiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shishir Kumar Singh |
| Designation |
Associate Professor & HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD number 32 Department of Paediatrics National Institute of Homoeopathy Block GE Sector 3 Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8240898749 |
| Fax |
|
| Email |
drshishirsinghmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shishir Kumar Singh |
| Designation |
Associate Professor & HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD number 32 Department of Paediatrics National Institute of Homoeopathy Block GE Sector 3 Kolkata
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8240898749 |
| Fax |
|
| Email |
drshishirsinghmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106 |
| 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 Amiya Dash |
National Institute of Homoeopathy |
OPD number 32 Department of Paediatrics National Institute of Homoeopathy Block GE Sector 3 Kolkata
North Twentyfour Parganas
WEST BENGAL |
09938995002
homeoamiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
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 |
Individualized Homoeopathic medicine in LM potency |
Administering indicated homoeopathic medicine for a period of 6 months, as decided appropriate to the case. Potency: Medicine will be dispensed in 50 Millesimal potency. Dispensing:Drug will be dispensed as 1 medicated globule, size "10", mixed in 100 ml of distilled water. Rectified spirit will be added for preservation of the medicine and patient will be advised to give 10 strokes before consuming it. Dosage and repetition will be as per homoeopathic principles and individual requirement of the case. Duration of therapy: 6 months for each individual patient. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient in the age group of 3 to 17 years.
2.All gender, regions and races irrespective of socioeconomic status.
3.Patients fulfilling Hanifin and Rajka diagnostic criteria for atopic dermatitis.
4.Absolute eosinophil count (AEC) more than 500 cells per mm
5.Patients already undergoing oral/topical conventional therapy for Atopic dermatitis may be
recruited after a washout period of 1 month.
6.Parent or guardian willing to give written consent; assent from children (Below 7 years: no assent
required,7 to 11 years Verbal assent ,more than 12 years written assent)
7.Parent orguardian (or child, if more than 7 years) ability to understand Bengali or Hindi or English. |
|
| ExclusionCriteria |
| Details |
1.Complicated cases of atopic dermatitis.
2.Patients with congenital anomalies, critically ill patients, 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 |
| Absolute eosinophil count (AEC) |
Measured at baseline and after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SCORAD Index |
Measured at baseline and after 6 months of treatment. |
| Modified Naranjo Criteria for Homeopathy (MONARCH) |
Measured at 6 months after treatment |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/12/2025 |
| 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="1"
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 (ICD10 L20.9) is a chronic, non-communicable, relapsing skin condition that predominantly affects infants and children, though it may present at any age. Its persistent nature often leads to considerable impairment in the quality of life of both patients and their families, with the recurring course exerting a negative influence on the developmental years of childhood. Homoeopathy is regarded as having wide applicability in the management of dermatological disorders, with potential benefits in controlling acute flare ups as well as addressing long standing cases. This study will involve paediatric patients diagnosed with atopic dermatitis, enrolled according to specified inclusion criteria. Each participant will receive individualized homoeopathic treatment in LM potency, prescribed on the basis of symptom similarity and tailored to the needs of the individual case. The primary outcome will be assessed through measurement of Absolute Eosinophil Count (AEC), while secondary outcomes will be evaluated using the SCORAD index and the Modified Naranjo Criteria for Homoeopathy (MONARCH). Patient enrolment will span twelve months, with each child being followed and evaluated for a period of six months.
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