| CTRI Number |
CTRI/2025/09/095054 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of homoeopathic medicine Nerium Oleander in cases of eczema using scale (scorad index) |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFICACY OF HOMEOPATHIC MEDICINE NERIUM OLEANDER IN THE TREATMENT OF ATOPIC DERMATITIS USING SCORAD INDEX |
| Trial Acronym |
NEO-AD Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Yogendra Tiwari |
| Designation |
MD Scholar |
| Affiliation |
Anand Homoeopathic Medical College And Research Institute,Anand |
| Address |
Room number 210, Department of homoeopathic materia medica, 1st floor, Anand Homoeopathic medical College and research institute near sardarbaug bhalej road
Anand
GUJARAT
388001
India |
| Phone |
7016172758 |
| Fax |
|
| Email |
tiwarisonal091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bankim A Patel |
| Designation |
Associate Professor - Homoeopathic Materia Medica |
| Affiliation |
Anand Homoeopathic Medical College And Research Institute,Anand |
| Address |
Room number 211, Department of homoeopathic materia medica, 1st floor, Anand Homoeopathic medical College and research institute near sardarbaug bhalej road
Anand
GUJARAT
388001
India |
| Phone |
9428066383 |
| Fax |
|
| Email |
pramukh.homeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bankim A Patel |
| Designation |
Associate Professor - Homoeopathic Materia Medica |
| Affiliation |
Anand Homoeopathic Medical College And Research Institute,Anand |
| Address |
Room number 211, Department of homoeopathic materia medica, 1st floor, Anand Homoeopathic medical College and research institute near sardarbaug bhalej road
Anand
GUJARAT
388001
India |
| Phone |
9428066383 |
| Fax |
|
| Email |
pramukh.homeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homoeopathic And General Hospital opposite sardar Baugh near new Bus stand Anand 388001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Dr Sonal Yogendra Tiwari |
| Address |
32,33 Shubham Park Society Near Brts Bus Stand Simada Varachha Road Surat |
| Type of Sponsor |
Other [Self ] |
|
|
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 Sonal Yogendra Tiwari |
Anand Homoeopathic And General Hospital |
Opd room number 01-Department of medicine Anand Homoeopathic And General Hospital Opp Sardar Baug Bhalej Road
Anand
GUJARAT |
7016172758
tiwarisonal091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee anand Homoeopathic medical and research institute |
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 |
Nerium Oleander |
Selection Of Potency Will Be Based On Totality Of Symptoms And Susceptibility Of Patient And The Case Will Be Reviewed Every 7 And 15 Days Depending Upon The Requirement Of The Case. And Assessment By SCORAD Index Will Be Done . |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i.Patients diagnosed with Atopic Dermatitis as per Hanifin and Rajka criteria and serum IgE levels.
ii.Patients of age groups from 18 to 60 years.
iii.Patient whose SCORAD index would be mild to moderate in terms of severity.
iv.Patients who have not taken any antihistamines or corticosteroids for at least 7 days prior to the start of treatment.
v.Patients willing to give informed consent and comply with the study protocol.
|
|
| ExclusionCriteria |
| Details |
i.Patients with suffering from secondary infection like presence of infected eczema, impetigo, eczema herpeticum, or other acute bacterial and viral skin infections.
ii.Patients with age less than 18 years and more than 60 years.
iii.Patients with severe SCORAD scored disease should not be considered.
iv.Patients who have taken any antihistamine or corticosteroid for at least 7 days prior to treatment with homoeopathic medicine.
v.Patients with other dermatological conditions co-existing chronic skin diseases like psoriasis, seborrheic dermatitis, contact dermatitis, etc., that may interfere with diagnosis or outcome.
vi.Patients with immunocompromised status, autoimmune diseases, or systemic infections.
vii.Pregnant or lactating women ,unless ethically approved and monitored.
viii.Patients who are unable or unwilling to comply with the study protocol, such as adhering to treatment regimen and attending follow-up visits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in SCORAD Index (Scoring Atopic Dermatitis Index) score from baseline to end of treatment. |
00-03 months for enrollment of cases |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Visual Analogue Scale VAS for pruritus and sleep loss.
|
3rd , 6th , 9th months |
| Proportion of participants achieving equal to or more than 50 percentage reduction in SCORAD index score |
3rd,6th,9th month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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
|
This prospective clinical trial aims to evaluate the efficacy of the homeopathic medicine Nerium oleander in patients with atopic dermatitis. Nerium oleander, prepared from the Oleander plant, is traditionally used in homeopathy for skin disorders marked by intense itching, inflammatory eruptions, and excoriations—features that resemble atopic dermatitis. Participants will receive individualized homoeopathic treatment with Nerium oleander. Disease severity and treatment response will be assessed monthly using the validated SCORAD (Scoring Atopic Dermatitis) index, which integrates objective signs, subjective symptoms (pruritus, sleep loss), and overall extent of disease. |