| CTRI Number |
CTRI/2023/03/051089 [Registered on: 27/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A survey study to get the prevalence of Depression in medical and paramedical students using depression scales
|
|
Scientific Title of Study
|
Prevalence of Depression in students of medical and Paramedical of Parul University; A Cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malavika B |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research, Parul University |
| Address |
Room no. 301, Department of Kayachikitsa, Parul Institute of Ayurved and Research, Parul University, p.o. Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9980072909 |
| Fax |
|
| Email |
malavikablk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Malavika B |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research, Parul University |
| Address |
Room no 301, Department of Kayachikitsa,Parul Institute of Ayurved and Research, Parul University, p.o. Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9980072909 |
| Fax |
|
| Email |
malavikablk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malavika B |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Ayurved and Research, Parul University |
| Address |
Room no 301, Department of Kayachikitsa,Parul Institute of Ayurved and Research, Parul University, p.o. Limda, Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9980072909 |
| Fax |
|
| Email |
malavikablk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and Research, Parul University, Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Malavika B |
| Address |
Assistant Professor, Department of Kayachikitsa, Parul Institute of Ayurved and Research, Parul University, Vadodara, Gujarat |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Malavika B |
Parul Institute of Ayurved and Research |
Dept of Kayachikitsa,PIAR, Parul University, Vadodara, Gujarat
Vadodara
GUJARAT |
9980072909
malavikablk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Parul University students of medical and paramedical faculties of MBBS, BAMS, BHMS, Pharmacy and Nursing |
|
| ExclusionCriteria |
| Details |
People suffering from secondary depression |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of depression using HAM D and DASS |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of depression in males, females, age-wise prevalence |
6 months |
|
|
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)
|
01/04/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study is a single ar, cross sectional study to find the prevalence of depression in medical and paramedical students using Hamilton Depression scale and Depression Anxiety Stress scale. The study will be carried out in 300 samples of students in Parul University, Gujarat, India within a period of 6 months. The primary outcome measures will bethe prevalence of depression in students. |