| CTRI Number |
CTRI/2025/03/081730 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment for atopic eczema using fifty millesimal potency. |
|
Scientific Title of Study
|
Effect of individualized homoeopathic medicine in cases of atopic eczema using fifty millesimal potency : an open - label observational 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 |
Darsha K |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14, Department of Organon of Medicine.
National Institute of Homoeopathy, GE Block, Sector - III, Salt Lake, Kolkata - 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9496043280 |
| Fax |
|
| Email |
darshadivakaran1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indrani Chakrabarti |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14, Department of Organon of Medicine, National Institute of Homoeopathy, GE Block, Sector-III, Salt Lake, Kolkata - 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902555 |
| Fax |
|
| Email |
indrani.abc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrani Chakrabarti |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14, Department of Organon of Medicine, National Institute of Homoeopathy, GE Block, Sector-III, Salt Lake, Kolkata - 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902555 |
| Fax |
|
| Email |
indrani.abc@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE Block, Sector - III, Salt Lake, Kolkata - 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE Block, 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 Darsha K |
National Institute of Homoeopathy |
OPD room no:14, Department of Organon of Medicine.
National Institute of Homoeopathy, GE Block
, Sector - III, Salt Lake, Kolkata - 700106
Kolkata
WEST BENGAL |
9496043280
darshadivakaran1999@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: L20||Atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine in fifty millesimal potency. |
All patients will be prescribed individualized homoeopathic medicine after detailed case taking in accordance with the directions given by Dr.C.F.S Hahnemann in Organon of Medicine 6th edition. Indicated individualized homoeopathic medicine in fifty millesimal potency will be prescribed. Dose and frequency of medicine will be decided as per the homoeopathic principles. Follow up will be done monthly till 6 months from the baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with atopic eczema who fulfill the Hanifin and Rajka diagnostic criteria.
2. Patients between the ages of 18 and 60 years.
3. Patients of both genders, all religious backgrounds, and any socioeconomic status.
4. Patients who are literate, who can read/ understand either english, hindi, bengali.
5. Patients who are willing to participate in the study and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with other dermatological conditions, serious systemic illnesses, psychiatric
disorders, or any other life-threatening illnesses.
2. Women who are pregnant or lactating.
3. Patients who are currently under substance abuse or dependence.
4. Patients who has been under Homoeopathic treatment within 3 months for any chronic
illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Eczema Area and Severity Index (EASI)
2. Validated Investigator Global Assessment for Atopic Dermatitis(vIGA-AD) |
Baseline and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dermatology Life Quality Index (DLQI) |
Baseline and 6th month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
17/03/2025 |
| 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="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
|
Atopic eczema is a chronic, inflammatory, non-communicable skin condition characterized by intense itching, relapsing episodes, and a strong association with atopic diathesis. It commonly manifests in childhood but can persist into adulthood, significantly impacting quality of life. Homoeopathic treatment is frequently sought for eczema, yet research on its efficacy, particularly using fifty millesimal (LM) potency, remains limited. This study aims to evaluate the effect of individualized homoeopathic treatment using LM potency on atopic eczema. Conducted over 12 months, each of the 64 participants will be followed for 6 months post-inclusion. The study will assess changes in the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), and quality of life using the Dermatology Life Quality Index (DLQI). Participants will be recruited from the inpatient and outpatient departments at the National Institute of Homoeopathy. Screening involves a detailed clinical assessment, including history-taking and evaluation of atopic conditions. Data collection will include both qualitative and quantitative measures, analyzed using statistical methods. The study adheres to Institutional Ethical Committee (IEC) guidelines, with findings intended for academic dissemination and potential publication. The score obtained by the patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals. |