| CTRI Number |
CTRI/2025/02/081482 [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 to find out the relationship between emotional stress and Type II Diabetes Mellitus |
|
Scientific Title of Study
|
The relationship between emotional stress and type II diabetes mellitus: a case-control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1319-0471 |
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: E11||Type 2 diabetes mellitus, |
|
|
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 type II DM [HbA1c= 6.5 or higher](for ‘cases’)
2. Person without type II DM (for ‘controls’)
3. Providing with written informed consent voluntarily
|
|
| ExclusionCriteria |
| Details |
1. co-morbidities that could independently cause stress (e.g., cancer)
2. Vulnerable population – unconscious, too sick for consultation, non-ambulatory, differently abled, terminally or critically ill patients, mentally incompetent people
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 association between emotional stress and Type II Diabetes mellitus.
|
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out the strength of association between emotional stress and type II diabetes mellitus.
2.To find out the severity of the stress by “Social Readjustment Rating Scale (2022)”
3.To find out type of emotion causing emotional stress in type II diabetes mellitus by the “Discrete Emotion Questionnaire”. |
At the end of the study. |
|
|
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 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 estimate the association between emotional stress and type II Diabetes mellitus.Population are male and female along with all socio-economic status suffering from type II DM (for ‘cases’)or without type II DM (for ‘controls’) .Eligible participants will be identified by measuring HbA1c =6.5 or higher (for ’cases’). 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. Controls will be matched to cases based on age group, gender and socio-economic status.Stress will be assessed by "Social Readjustment Rating Scale". Assessment of type of emotion causing emotional stress will be done by the "Discrete Emotion Questionnaire".
|