| CTRI Number |
CTRI/2024/06/069010 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of physical activity and diet in patients with depression |
|
Scientific Title of Study
|
Physical activity levels, Dietary patterns and biomarkers in patients with depression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshara Awasthi |
| Designation |
Junior resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9452751106 |
| Fax |
|
| Email |
akshara.awasthi.12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Jain |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604354 |
| Fax |
|
| Email |
drpreetijain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Jain |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604354 |
| Fax |
|
| Email |
drpreetijain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College New Delhi -110002
India
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College New Delhi -110002 India |
| 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 Akshara Awasthi |
Maulana Azad Medical College New Delhi |
Department of Physiology,
Maulana Azad Medical College
New Delhi
Central
DELHI |
9452751106
akshara.awasthi.12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and associated hospitals Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Treatment naive, newly diagnosed patients of mild and moderate depression |
|
| ExclusionCriteria |
| Details |
Patient suffering from serious mental illness,on weightloss medication, pregnant and lactating women and patients of known chronic diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants having light physical activity. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) proprtion of participants having inadequate nutrient intake
2) Comparison of Peripheral blood levels of adiponectin, cortisol, IL6, CRP, metabolic and nutritional biomarkers in participants.
3) association of Physical Activity level, dietary patterns and biomarkers in participants |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/06/2024 |
| 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 - NO
|
|
Brief Summary
|
The present study is designed to assess the Physical activity level, Dietary patterns and Biomarkers of Patients diagnosed with Depression and compare their data with healthy controls. Study will be conducted in the Department of Physiology MAMC and Department of Psychiatry GIPMER New Delhi. |