CTRI Number |
CTRI/2020/07/026952 [Registered on: 31/07/2020] Trial Registered Prospectively |
Last Modified On: |
28/07/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Screening |
Study Design |
Single Arm Trial |
Public Title of Study
|
Survey and Management
of depression, Anxiety and Stress due to COVID-19 fear |
Scientific Title of Study
|
Survey on depression, anxiety and stress during Covid-19 in general population of Hassan district and its management with Brahmi (Bacopa monnieri (L.) Pennell) |
Trial Acronym |
DAS-COVID-19-AYU |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Prasanna N Rao |
Designation |
Principal and Chief Medical Officer |
Affiliation |
SDM College of Ayurveda and Hospital, Hassan |
Address |
Ayurveda, Room no. 12, SDM Hospital, B.M. Road, Thanniruhalla, Hassan Hassan KARNATAKA 573201 India |
Phone |
9448064277 |
Fax |
|
Email |
profpnrao@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Prasanna N Rao |
Designation |
Principal and Chief Medical Officer |
Affiliation |
SDM College of Ayurveda and Hospital, Hassan |
Address |
Ayurveda, Room No. 12, SDM Hospital, B.M. Road, Thanniruhalla, Hassan Hassan KARNATAKA 573201 India |
Phone |
9448064277 |
Fax |
|
Email |
profpnrao@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shailaja U |
Designation |
Professor and Head |
Affiliation |
SDM College of Ayurveda and Hospital, Hassan |
Address |
Ayurveda Pediatrics, Room No. 16, SDM Hospital, B.M. Road, Thanniruhalla, Hassan Hassan KARNATAKA 573201 India |
Phone |
9448816433 |
Fax |
|
Email |
rao.shaila@gmail.com |
|
Source of Monetary or Material Support
|
Dr Prasanna N Rao, Principal and Cheif Medical Officer, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B.M. Road, Thanniruhalla, Hassan, Karnataka |
|
Primary Sponsor
|
Name |
SDM College of Ayurveda and Hospital |
Address |
SDM College of Ayurveda and Hospital, B.M. Road, Thanniruhalla, Hassan |
Type of Sponsor |
Private 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 Prasanna N Rao |
SDM College of Ayurveda and Hospital |
Room no. 12 and 16, SDM Ayurveda Hospital building Hassan KARNATAKA |
9448064277
profpnrao@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SDM College of Ayurveda and Hospital, Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
General population those prone to get depression, anxiety and stress due to COVID-19 fear |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Brahmi capsule |
Two capsule (500 mg each) twice a day orally |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Subjects within 12 to 60 years of age |
|
ExclusionCriteria |
Details |
Subjects below 12 years and above 60 years |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in depression, anxiety and stress |
60 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Survey on the prevalence of depression, anxiety and stress during COVID-19 |
60 days |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
01/08/2020 |
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="2" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
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)?
|
Brief Summary
|
The aim of the study is to understand the prevalence of symptoms of depression, anxiety and stress in general population during COVID-19 in Hassan district and to evaluate the effectiveness of Brahmi capsule in depression, anxiety and stress during COVID-19 in Hassan district. 1000 subjects will be surveyed using DASS 21 scale for 30 days and from that 200 subjects will be administered with Brahmi capsule for a period of 30 days. Later the subjects will be assessed again using DASS 21 for probable reduction in depression, anxiety and stress. |