| CTRI Number |
CTRI/2025/02/080112 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Survey on Depression, Anxiety and Stress in Non-communicable diseases |
|
Scientific Title of Study
|
A multi-centric cross-sectional survey to assess the magnitude of Depression, Anxiety and Stress in patients with non-Communicable diseases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Clinical research Department, room No. 417, D Block Janakpuri Institutional Area ,Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
9818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Clinical research Department, room No. 417, D Block Janakpuri Institutional Area, Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
9818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Clinical research Department, room No. 417, D Block Janakpuri Institutional Area, Janakpuri,New Delhi
South West
DELHI
110058
India |
| Phone |
9818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Janakpuri, New Delhi,India, 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
D Block, Janakpuri Institutional Area, Janakpuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uttam Singh |
Central Research Institute (H), Jaipur |
Room No. 6, Central Research Institute for Homoeopathy,Sector-26,Pratap Nagar,Jaipur-302033,Rajasthan
Jaipur
RAJASTHAN |
9679593673
druttam01@gmail.com |
| Dr Pankhuri Mishra |
Dr. D.P. Rastogi Central Research Institute (H), Noida |
Room No. 205,Dr D.P. Rastogi Central Research Institute of Homoeopathy, A-1/1,Sector 24, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9968533904
drpankhuri7hc@gmail.com |
| Dr R Bhuvaneswari |
National Homoeopathy Research Institute in Mental Health |
Room No. 106, National Homoeopathy Research Institute in Mental Health Sachivothamapuram (PO)Kurichy Kottayam Kerala 686532
Kottayam
KERALA |
8281475541
drbhuvaneswarir@gmail.com |
| Dr Amulya Ratna Sahoo |
Regional Research Institute (H), Guwahati |
Room No. 102, Ground Floor, CARI Old Building, (Ayurvedic Campus), Barsojai (Bhetapara), P.O. Beltola Guwahati 781028
Kamrup
ASSAM |
8763721546
drarsahoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee (Guwahati) |
Approved |
| Institutional Ethics Committee (Jaipur) |
Approved |
| Institutional Ethics Committee (Kottayam) |
Approved |
| Institutional Ethics Committee (Noida) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL as this is an observational survey |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both genders and Age above 18 years
Diagnosed cases of non-communicable diseases
Patients willing to participate in the study
Symptom History of 3 months as Symptoms of anxiey and stress are noticed commonly after diagnosis of NCD, which wanes off over a period. Symptoms persisting beyond 3 months should be considered as pathological.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from known psychiatric and neurocognitive disorders except (depression, anxiety and stress)
Persons not willing to provide consent for the study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the prevalence of depression, anxiety and stress in diagnosed cases of non-communicable diseases through DASS-21 scale. |
Outcome will be assesed at Baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1068"
Sample Size from India="1068"
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)
|
01/03/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A multi-centric cross-sectional survey will be conducted to assess the magnitude of Depression, Anxiety and Stress in patients with non-Communicable diseases. Diagnosed patients of non-communicable diseases such as diabetes mellitus, hypertension, , chronic respiratory diseases, cardiovascular diseases and cancer will be included to assess the prevalence of depression, anxiety & stress in them through structured questionnaire consisting of Socio-demographic details, clinical and lifestyle conditions regarding the NCD and DASS-21 scale. |