| CTRI Number |
CTRI/2025/06/088868 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Medicines For Seborrheic Dermatitis |
|
Scientific Title of Study
|
The Effect Of Individualized Homoeopathic Medicines In Fifty-Millesimal Potency In Treatment Of Seborrheic Dermatitis And
Its Relationship With Tubercular Diathesis: An Open-Label,
Single-Arm, Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1321-4018 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Prashanta Hembrom |
| Designation |
Post Graduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department Of Practice Of Medicine
265,266 Acharya Prafulla Chandra Road,Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
8981521101 |
| Fax |
|
| Email |
prashantahembrom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department Of Practice Of Medicine
265,266 Acharya Prafulla Chandra Road,Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department Of Practice Of Medicine
265,266 Acharya Prafulla Chandra Road,Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College And Hospital,265,266 Acharya Prafulla Chandra Road, Kolkata-700009,West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College And Hospital |
| Address |
265,266 Acharya Prafulla Chandra Road,Kolkata-700009,West Bengal |
| 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 Prashanta Hembrom |
The Calcutta Homoeopathic Medical College And Hospital |
Department Of Practice Of Medicine
265,266 Acharya Prafulla Chandra Road,Kolkata-700009
Kolkata
WEST BENGAL |
8981521101
prashantahembrom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individual Homoeopathic Medicine in 50 millesimal potency |
Intervention is planned as administering indicated
homoeopathic medicines in Q (50 millesimal) potencies, as decided appropriate to
the case or condition. In 50 millesimal scale, each dose shall consist one globule no:
10 of the indicated remedy is dissolved in 120 ml (8 table spoonful) of dist. water
with addition of some rectified spirit then the vial is succussed and after that one
table spoon (approx. 15ml) of the medicinal solution is taken and put in a glass of
water of about 120 ml (8 table spoonful). This is stirred thoroughly and from it a
dose (1 tea spoonful) 5ml is given to the patient to be taken orally in empty stomach.
Dose and amp; repeatation depending upon the individual requirement of the case.Each enrolled participants will receive advice on applying coconut or olive oil
on the affected part and will be given advice to refrain from taking tea, coffee,
alcoholic beverages like whisky, brandy etc, and foods possessing medicinal
qualities like onion, pepper, cloves, cinnamon, ginger, and bitter substances and
wearing tight garments including synthetic cloths and to keep maintaining local
hygiene . All medicines will be procured from a Good Manufacturing Practice
(GMP) certified firm.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed cases of SD [ICD Code 11 – EA81.0, EA81.1, 9A06.71]
2. Patient aged 18 – 65 years of all genders
3. Patient not receiving any topical treatment for SD since last 3 months
4. Patients already undergoing homoeopathic treatment for SD, underwent a wash
out period of 1.5 months or 6 weeks. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Associated systemic or immune compromised illness.
3. Patients who are too sick for consultation.
4. Diagnosed cases of any life threatening, malignant or Psychiatric illness
5. Simultaneous participation in any other clinical trials |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life assessment using DLQI (Dermatology Life Quality Index) |
At baseline every one month, for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of tubercular diathesis (TD) and its association with seborrheic
dermatitis by using Tubercular Diathesis questionnaire {approved by
Institutional Expert Committee (Homoeopathic Philosophy)}
2. Assessment of the presence of Tubercular (Pseudo-psora & Scrofula)
symptoms among the constitutionally selected medicine with the help of
different homoeopathic materia medica. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
25/06/2025 |
| 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 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
|
Seborrheic dermatitis (SD) is a common inflammatory skin disease presenting with a papulosquamous morphology in areas rich in sebaceous glands, particularly the scalp, face, and body folds. There are multiple factors associated with the development of SD, and their disparate nature has led to many proposals about its cause and pathogenesis. The onset of SD appears linked to the interplay of normal microscopic skin flora (especially Malassezia spp.), the composition of lipids on the skin surface, and individual susceptibility. Following screening using specific selection(inclusion and exclusion criteria) criteria and obtaining consent , eligible 37 participants will be included in the trial .Individualized Homoeopathic Medicines will be prescribed in 50 millesimal potency after proper case-taking, consultation with Materia medica and Repertory. Following that, the outcomes will be assessed initially at the baseline and every one month up to 3 months as per DLQI scale. The tubercular diathesis assessment will be done based on tubercular diathesis questionnaire. |