| 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. |