| CTRI Number |
CTRI/2025/12/099916 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the role of individualised homeopathic medicine in management of paediatric atopic dermatitis by using SCORAD index |
|
Scientific Title of Study
|
ASSESSING THE ROLE OF INDIVIDUALISED HOMEOPATHIC MEDICINE IN MANAGEMENT OF PAEDIATRIC ATOPIC DERMATITIS BASED ON SCORing ATOPIC DERMATITIS INDEX |
| 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 Yasmin Sunkesula |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homeopathic Medical College and Hospital |
| Address |
OPD no 1 Department of Paediatrics JIMS Homeopathic Medical College and Hospital
Sriramnagar Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
TELANGANA
OPD no 1 Department of Paediatrics JIMS Homeopathic Medical College and Hospital
Sriramnagar Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
TELANGANA
Hyderabad
TELANGANA
509325
India |
| Phone |
7993771615 |
| Fax |
04023470444 |
| Email |
yasmin.sunkesula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammed Irfan |
| Designation |
Professor |
| Affiliation |
JIMS Homeopathic Medical College and Hospital |
| Address |
OPD no 1 Department of Paediatrics JIMS Homeopathic Medical College and Hospital
Sriramnagar Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
TELANGANA
OPD no 1 Department of Paediatrics JIMS Homeopathic Medical College and Hospital
Sriramnagar Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
TELANGANA
Hyderabad
TELANGANA
509325
India |
| Phone |
9010858281 |
| Fax |
04023470444 |
| Email |
dr.mohamedirfan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yasmin Sunkesula |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homeopathic Medical College and Hospital |
| Address |
OPD no 1 Department of Paediatrics JIMS Homeopathic Medical College and Hospital
Sriramnagar Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
TELANGANA
OPD no 1 Department of Paediatrics JIMS Homeopathic Medical College and Hospital
Sriramnagar Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
TELANGANA
Hyderabad
TELANGANA
509325
India |
| Phone |
7993771615 |
| Fax |
04023470444 |
| Email |
yasmin.sunkesula@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIMS Homeopathic Medical College and Hospital |
| Address |
JIMS Homeopathic Medical College and Hospital
Sriramanagar
Muchintal
Hyderabad
TELANGANA |
| 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 Yasmin Sunkesula |
JIMS Homeopathic Medical College and Hospital |
JIMS Homeopathic Medical College and Hospital
Sriramanagar
Muchintal Village Palamakula
PO Shamshabad Mandal
Hyderabad
509325
TELANGANA
Inia
Hyderabad
TELANGANA |
7993771615
04023470444
yasmin.sunkesula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIMS Homeopathic Medical College and Hospital |
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 |
Individualised Homeopathic Medicine |
One Powder Packet Weekly once at Morning Empty Stomach |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes between the age group of five to twelve years diagnosed with atopic dermatitis are included in the study and their symptoms and severity are assessed using the SCORAD scale with scores ranging from fifteen to fifty indicating mild to moderate dermatitis symptoms and only children fitting within this mild to moderate range are selected |
|
| ExclusionCriteria |
| Details |
Patients in emergency conditions or those taking other medications with associated systemic involvement and drug allergies as well as patients using conservative treatment and those presenting with a SCORAD score greater than fifty are excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To detect the changes in SCORAD index after administration of individualized homoeopathic
medicine in Paediatric age group suffering from atopic dermatitis within a duration of 6
months |
baseline second month fourth month and sixth month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/01/2026 |
| 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="0"
Days="0" |
|
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
|
Atopic dermatitis is a chronic inflammatory skin condition commonly affecting children and significantly impacting quality of life. Conventional treatments often provide only temporary relief and may cause adverse effects creating a need for safer long-term management options. This study aims to evaluate the effectiveness of individualized homeopathic medicine in children aged five to twelve years diagnosed with mild to moderate atopic dermatitis assessed using the SCORAD index. A total of thirty six patients fulfilling the inclusion and exclusion criteria will be selected through purposive sampling from OPD and IPD of JIMS Homoeopathic Medical College and Hospital. Detailed case taking constitutional assessment individualized remedy selection and follow up every twenty one days will be undertaken over a period of six months. Changes in SCORAD scores will serve as the primary outcome measure analysed using appropriate statistical methods. The study intends to determine whether individualized homeopathic treatment produces measurable improvement in the severity and symptomatology of atopic dermatitis thereby offering a holistic and safe therapeutic approach for paediatric patients. |