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CTRI Number  CTRI/2025/02/081473 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 13/08/2026
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)= "400"
Final Enrollment numbers achieved (India)="400" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2025 
Date of Study Completion (India) 04/08/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. 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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included Reserved DOI: 10.17632/xmbmsj7zwv.1).

  6. 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.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nill
Brief Summary
Modification(s)  		 This case-control study (N = 400; cases 200, matched controls 200) evaluated the independent association between prolonged grief and chronic disease status in adults. By employing a rigorous statistical framework involving 1:1 propensity score matching, frequentist Firth-penalized regression, and Bayesian multivariable modeling, the study successfully addressed selection bias and mathematical instability inherent in cross-sectional data. The analysis identified the Cultural Supplement: Accessory items (CSAI) total as a robust, independent predictor of chronic disease (crude Odds ratio [OR]: 1.57, adjusted OR: 1.74; matched OR: 1.73; Bayesian OR: 1.61, E-value: 1.97), whereas the International Prolonged Grief Disorder Scale (IPGDS) sub-scales did not retain independent significance after multivariable adjustment. These findings provide strong empirical evidence that elevated prolonged grief symptoms are significantly correlated with physical morbidity independent of baseline demographic and physiological characteristics, emphasizing the clinical necessity of integrating standardized psychosocial screening into long-term chronic disease management. 
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