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CTRI Number  CTRI/2020/06/025999 [Registered on: 21/06/2020] Trial Registered Prospectively
Last Modified On: 20/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patients 
Scientific Title of Study   Phase II, open label, randomized controlled trial to evaluate safety and efficacy of ShatPlus as an immunomodulator in adult Covid 19 positive patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/20-21/003 Ver. 2.0 dated, Dated 3rd June 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tushar V Patil 
Designation  Principal Investigator 
Affiliation  Pimpri Chinchwad Municiple Corporations YCM Hospital 
Address  Head of Department-Pathology, 1st floor, Room No. 127, Pimpri Chinchwad Municiple Corporations YCM Hospital, Pimpri, Pune 18.

Pune
MAHARASHTRA
411018
India 
Phone  8888844203  
Fax    
Email  tvpatil71@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pawan Kumar Singh 
Designation  Vice President 
Affiliation  BVG Life Sciences Ltd. (BVG Group) 
Address  Sagar Complex, Opposite Kasarwadi Railway Station, Near Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034

Pune
MAHARASHTRA
411034
India 
Phone  9409616256  
Fax    
Email  pawan.singh@bvglife.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pawan Kumar Singh 
Designation  Vice President 
Affiliation  BVG Life Sciences Ltd. (BVG Group) 
Address  Sagar Complex, Opposite Kasarwadi Railway Station, Near Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034

Pune
MAHARASHTRA
411034
India 
Phone  9409616256  
Fax    
Email  pawan.singh@bvglife.com  
 
Source of Monetary or Material Support  
BVG Life Sciences Ltd Sagar Complex, Opposite Kasarwadi Railway Station, Near Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034,India 
 
Primary Sponsor  
Name  BVG Life Sciences Ltd 
Address  Sagar Complex, Opposite Kasarwadi Railway Station, Near Nashikphata, Old Pune-Mumbai Road, Chinchwad, Pune - 411034, India 
Type of Sponsor  Research institution 
 
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 Tushar V Patil  Pimpri Chinchwad Municipal Corporatios YCM Hospital   Head of Department-Pathology, 1st floor, Room No. 127,YCM Hospital, Sant Tukaram nagar, Pimpri, Pune 18.
Pune
MAHARASHTRA 
8888844203

tvpatil71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PCMCs PGI YCMH Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ShatPlus along with standard treatment  10 ml thrice a day per oral ShatPlus along with standard treatment 
Comparator Agent  Standard treatment   Standard treatment as per protocol of ICMR 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients admitted with RT-PCR confirmed COVID-19 illness.
Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8)
Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.
 
 
ExclusionCriteria 
Details  Pregnant women
Breastfeeding women
Requiring ICU admission at screening
Patients above 65 years of age and below 18 Years
Past History of MI, Epileptic episodes
Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening
Any other condition by which subject proves unfit from investigator perspective
Not giving consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19
Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale
Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG
Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale
 
Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study 
 
Secondary Outcome  
Outcome  TimePoints 
Change in National Early Warning Score
Hematological parameters like WBS, HB and platelet count etc.
Requirement of admission to intensive care unit
Reduced hospital duration
Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Safety and tolerability of the intervention
Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc. 
Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   27/06/2020 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  
The coronavirus disease 2019 (COVID-19) is a global pandemic. Presently there is a quest of an
appropriate treatment which could arrest the fatality of the disease and also enhance the recovery
rate of the affected individuals. With years of rigorous R&D, BVG has developed ShatPlus
formulation, having immune-modulatory, anti-viral, immune-stimulant, anti-inflammatory and
anti-oxidant effects studied through scientific validation. The Ayurvedic ingredients used in the
above formulation are scientifically reported to have anti-viral effects. BVG Life Sciences Limited
herewith has planned clinical trial to clinical validate “ShatPlus”, an ayurvedic proprietary
medicine against COVID-19.
 
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