| CTRI Number |
CTRI/2025/02/081443 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A case-control study on suppression of skin disease causing systemic illness |
|
Scientific Title of Study
|
The association between history of suppression of skin diseases and development of systemic diseases: a case-control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1318-8095 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pulakendu Bhattacharya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy,D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8442992147 |
| Fax |
|
| Email |
drpulakendu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Principal in-charge and Administrator, Professor and HOD of Organon of Medicine |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy,D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhasish Ganguly |
| Designation |
Principal in-charge and Administrator, Professor and HOD of Organon of Medicine |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy,D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital,12 Gobinda Khatick Road, Tangra , Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road, Tangra , Kolkata 700046 |
| 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 Pulakendu Bhattacharya |
D N De Homoeopathic Medical College and Hospital |
OPD room no. PG1(Dept. of Organon of Medicine),Room no. 10 (Research),12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
8442992147
drpulakendu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (5) ICD-10 Condition: E70-E88||Metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All socio-economic status.
2. Patients suffering from any systemic diseases (for ‘cases’)
3. Person without any systemic diseases (for ‘controls’)
4. Giving voluntary informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing systemic diseases before the skin disease diagnosis.
2. Patients with multiple concurrent skin diseases.
3. Individuals undergoing concurrent treatments.
4. Vulnerable population and severe psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study is attempted to identify the association between the suppression of skin diseases and the development of systemic diseases, as observed in patients treated with conventional methods according to homoeopathic literature.
|
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To examine the type & severity of systemic diseases that develop following the suppression of skin conditions.
2.To investigate the time interval between skin disease suppression & the onset of systemic diseases.
3. To analyse whether patients with a history of skin disease suppression are at higher risk for developing chronic systemic diseases.
4. To assess how homoeopathic literature, aligns with the findings of this retrospective study regarding history of skin disease suppression & development of systemic diseases.
5. To identify any specific patterns in the progression of internal diseases when skin symptoms are suppressed, according to Hahnemann’s miasm.
|
At the end of 1 year. |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
10/03/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [drpulakendu@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
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
|
This is a case-control study to assess the relationship between the suppression of skin diseases and the development of systemic diseases, as observed in patients treated with conventional methods, as assumed in homoeopathic literature. Population are male and female along with all socio-economic status, suffering from any systemic diseases (for ‘cases’) or without suffering from any systemic diseases (for ‘controls’). The data will be collected retrospectively from OPDs of D. N. De Homoeopathic Medical college and Hospital, Kolkata. Data will be obtained through details case taking of the selected participants. Relevant information includes: Socio-demographic data, diagnosis and history of skin disease, treatment details (type of therapy, duration), follow-up records indicating the development of systemic diseases, laboratory investigations etc.To reduce confounding matching will be done on the basis of age group, gender and socio-economic status.
|