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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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. 
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