| CTRI Number |
CTRI/2025/08/093335 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the Role of Homoeopathic Medicines in Managing Eczema (Atopic Dermatitis) in adults aged 10 to 35 Years |
|
Scientific Title of Study
|
Effect of individualized homeopathic medicines in cases of atopic dermatitis in age group 10 to 35 years with SCORAD assessment - A case study design. |
| 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 Deepti Mahesh Yesade |
| Designation |
Professor |
| Affiliation |
SJPESs Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Materia Medica,
SJPESs Homoeopathic Medical College and Hospital,
200 E, Tararani Chowk, Kawala Naka,
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9403803599 |
| Fax |
|
| Email |
deepti.yesade81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar S Patil |
| Designation |
Principal, Professor and Guide |
| Affiliation |
SJPESs Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Materia Medica,
SJPESs Homoeopathic Medical College and Hospital,
200 E, Tararani Chowk, Kawala Naka,
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
7218677677 |
| Fax |
|
| Email |
hmc_h@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Mahesh Yesade |
| Designation |
Professor |
| Affiliation |
SJPESs Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Materia Medica,
SJPESs Homoeopathic Medical College and Hospital,
200 E, Tararani Chowk, Kawala Naka,
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9403803599 |
| Fax |
|
| Email |
deepti.yesade81@gmail.com |
|
|
Source of Monetary or Material Support
|
| SJPESs Homoeopathic Medical College and Hospital. |
|
|
Primary Sponsor
|
| Name |
Dr Deepti Mahesh Yesade |
| Address |
Dept. Of Materia Medica,
SJPESs Homoeopathic Medical College and Hospital,
200 E, Tararani Chowk, Kawala Naka, |
| 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 Deepti Mahesh Yesade |
SJPEs Homeopathic Medical College and Hospital, |
Dept. Of Materia Medica, Ground Floor,
SJPESs Homoeopathic Medical College and Hospital,
200 E, Tararani Chowk, Kawala Naka, Kolhapur,
Maharashtra, India.
Pincode-416003
Kolhapur
MAHARASHTRA |
9403803599
deepti.yesade81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
Individualized Homoeopathic Medicine chosen on the bases of totality of Symptoms. |
Route- Oral, Dose- 4 pills- TID X 3 days followed by Placebo-4 pills/ TID/ Monthly, Duration-3 months.
Future prescription according to follow up |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with age 10 to 35 yrs
2) Patients with both sexes
3) Patients having SCORAD calculator percentage upto 70% are included in study
4)Patients of all socioeconomic group are included in study
|
|
| ExclusionCriteria |
| Details |
1) Patients with SCORAD calculator percentage more than 70% are excluded from study
2) Patients with atopic dermatitis along with severe allergic rhinitis and asthma
3) Patients who are using long term steroid treatment and long term antiallergic drugs for atopic dermatitis
4) Patient suffering from life threatening or chronic conditions or immune compromised.
5) Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in SCORAD Score from base (0 Month) line to end of treatment.(3rd Month) |
0-Month and 3rd Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
01/09/2025 |
| 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="4"
Months="0"
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 clinical study assesses the efficacy of individualized homeopathic medicines in managing atopic dermatitis (AD) among 50 patients aged 10–35 years, using the validated SCORAD (Scoring Atopic Dermatitis) tool. Conducted over 4 years, the single-arm case study design excludes severe cases (SCORAD >70%), comorbidities, or long-term steroid users. Participants receive remedies tailored to symptom totality (itch, redness, oozing, lichenification, sleep loss), with plain coconut oil as the sole adjunct. SCORAD scores—evaluating lesion extent, intensity, and subjective symptoms—are measured at baseline and monthly follow-ups until remission. Statistical analysis (paired t-tests/Wilcoxon tests) will determine significance (p<0.05) in score reduction. Secondary objectives include analyzing frequently prescribed remedies (e.g., *Sulphur*, *Graphites*) and symptom patterns. The study addresses a critical evidence gap, as prior homeopathic AD trials involved small cohorts. By demonstrating non-invasive, personalized treatment potential, it aims to reduce reliance on conventional therapies (corticosteroids/immunosuppressants) and improve quality of life. Ethical approval and informed consent are secured, with vernacular (Marathi) documents ensuring participant accessibility. Outcomes may inform integrative dermatology protocols in India’s high-AD-burden setting. |