| CTRI Number |
CTRI/2025/02/081473 [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 of relationship between history of prolonged grief and development of chronic diseases |
|
Scientific Title of Study
|
Relationship between history of prolonged grief and development of chronic diseases in adults: a case-control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1317-1896 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyajit Naskar |
| 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 |
8981859153 |
| Fax |
|
| Email |
satya.naskar@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 Satyajit Naskar |
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 |
8981859153
satya.naskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee of D. N. De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system, (4) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (5) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (6) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (7) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
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.Patients suffering from any chronic diseases (for cases)
2.Person without chronic disease (for controls)
3.Giving voluntary informed consent. |
|
| ExclusionCriteria |
| Details |
1.Vulnerable population
2.Individuals with a known history of severe psychiatric disorders
3.Pregnancy, puerperium, lactation
4.Self- reported immune-compromised state |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will be estimated the relationship between history of prolonged grief and development of any chronic diseases among adults. |
At the end of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out the strength of association between h/o prolonged grief & development of chronic diseases among adults.
2.To find out the severity of prolonged grief in development of chronic diseases among adults using International Prolonged Grief Disorder Scale (IPGDS). |
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 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 - 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 [satya.naskar@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 28-02-2031?
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 history of prolonged grief and development of chronic diseases in adults. Population are male & female suffering with chronic diseases (for ‘cases’) or
without chronic diseases (for ‘controls’). The data will be collected retrospectively from OPDs of D. N. De Homoeopathic Medical College and Hospital, Kolkata.Prolonged grief disorder will be identified according to criteria defined on ICD-11 (WHO,2022)[ICD-11 code 6B42]. Severity assessment of prolonged grief disorder will be done by using International Prolonged Grief Disorder Scale(IPGDS). Anonimity of the participants will be protected.
|