| CTRI Number |
CTRI/2025/08/093536 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Long-term effects of homeopathic medicine on chronic skin disease in adults |
|
Scientific Title of Study
|
A longitudinal quantitative study documenting homoeopathic treatment outcomes in chronic dermatological conditions in adults using the Patient Response Assessment Tool after Homoeopathic Treatment version 2.0 (PRATHoT v.2.0) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-3983 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mousumi Nath |
| Designation |
Postgraduate trainee |
| Affiliation |
D.N.DE Homoeopathic Medical college and hospital |
| Address |
Dept. of Organon of Medicine, Room no.- PG-1, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007711140 |
| Fax |
|
| Email |
mousuminath690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mousumi Nath |
| Designation |
Post graduate trainee |
| Affiliation |
D.N.DE Homoeopathic Medical college and hospital |
| Address |
Dept. of Organon of Medicine, Room no.- PG-1, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007711140 |
| Fax |
|
| Email |
mousuminath690@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangita Saha |
| Designation |
Professor |
| Affiliation |
D.N.DE Homoeopathic Medical college and hospital |
| Address |
Dept. of organon of Medicine, 12,Gobinda Khatick Road, Kolkata-700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433989717 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.N.DE Homoeopathic Medical college and hospital, Govt. of West Bengal,12,Gobinda khatick Road, Kolkata-700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical college and hospital |
| Address |
12,Gobinda Khatick Road , kolkata-700046, 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 Mousumi Nath |
D N De Homoeopathic Medical college and Hospital |
Dept. of organon of Medicine, Room No. 9 (Skin OPD), and PG 1 OPD, 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
9007711140
mousuminath690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized
homeopathic
medicines |
The intervention is planned to involve administering
indicated homeopathic medicines in centesimal
potencies (CH). Each dose will consist of 3-4 globules
(No. 30) of cane sugar, moistened with the indicated
medicine (preserved in 90% v/v ethanol), to be taken
orally on an empty stomach; dosage and repetition will
depend on the individuals requirements. Patients will
be advised to refrain from handling the globules or
from eating, drinking, smoking, or brushing their teeth
within 30 minutes of taking the globules and will be
asked to suck the globules rather than simply
swallowing them. Single, individualized medicine will be
prescribed on each occasion, considering the totality of
presenting symptoms, clinical history details,
constitutional features, miasmatic expressions, and
repertorization using HOMPATH/RADAR software when
required, with due consultation of the Materia Medica
and consensus among three homoeopaths. All the
medicines and sundry items will be procured from a
Good Manufacturing Practice (GMP) certified firm.
Provision will be made to adjust the medicines or
potencies and dosage in subsequent visits whenever
required, following the principles of classical
homeopathy, and such instances will be compared
between groups. During the three-month intervention
period, all enrolled patients will receive advice on
dietary guidelines and lifestyle modification. Reminding
participants verbally over the phone once a week and
during each follow-up visit will help ensure they follow
the advice. Duration of therapy: 3 months. |
| Comparator Agent |
NIL |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Suffering from any chronic dermatological complaints.
2.Either sex or transgender
|
|
| ExclusionCriteria |
| Details |
1. Patients denying written informed consent.
2. Patient taking homoeopathic treatment for any chronic disease within the last 6 months.
3. Simultaneous participation in any other clinical trial.
4. Unconscious, differently abled, non-ambulatory, too sick for consultation, terminally or critically ill patients, mentally incompetent.
5. Pregnant, puerperal and lactating women
6. Self-reported immunocompromised state, AIDS, hepatitis etc.
7. Diagnosed and probable case of skin cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient Response Assessment Tool after Homeopathic Treatment (PRATHoT; version 2.0) |
After enrollment every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| outcome related to impact on daily living (ORIDL) score |
After enrollment every month, up to 3 months |
| The Dermatology Life Quality Index (DLQI) score |
At baseline, monthly, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/09/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mousuminath690@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The term "chronic dermatological condition" is an umbrella term used to describe skin disorders characterized by repeated episodes and prolonged duration. The American Academy of Dermatology (AAD) generally defines chronic dermatological conditions as those that are long-lasting or persistent, often with periods of flare-ups and remission. These conditions can significantly impact a person’s quality of life due to their long duration and potential for symptom recurrence. Conditions such as acne, eczema, psoriasis, and rosacea not only affect the skin but also have significant psychological and social impacts. Their visible nature often leads to emotional distress, reduced self-esteem, and, in some cases, social withdrawal or clinical depression. These effects are experienced universally, across all cultures, age groups, and socioeconomic backgrounds, making skin disorders among the most common medical complaints worldwide. Effective treatment of these conditions can improve both physical appearance and mental well-being, highlighting the importance of addressing the broader impacts of dermatological conditions beyond just the surface symptoms. The Global Burden of Disease project 2017 has shown that dermatological conditions continue to be the 4th leading cause of nonfatal disease burden world-wide. Under such circumstances, we intend to undertake this research project ‘A longitudinal quantitative study documenting homoeopathic treatment outcomes in chronic dermatological conditions in adults using the Patient Response Assessment Tool after Homoeopathic Treatment version 2.0 (PRATHoT v.2.0) on 300 patients suffering from chronic dermatological conditions at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by PRATHoT [Primary outcome measure], ORIDL [Secondary outcome measure], DLQI[Secondary outcome measure] every month up to 3 months.
|