CTRI Number	CTRI/2020/05/025340 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On:	24/05/2021
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 in SARS-CoV-2 Infection.
Scientific Title of Study Modification(s)	Clinical trial to evaluate the safety and efficacy of ShatPlus an Ayurvedic Proprietary Medicine as an intervention in adult patients with SARS-CoV-2 infection.
Secondary IDs if Any Modification(s)	Secondary ID  Registry  PROTOCOL NO- MHC/CT/20-21/001 Ver. 2.0, Dated 25th May 2020  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Patsute Sudhir Dadaram  Address  Naidu Hospital, Infectious Diseases Centre, Pune Municipal Corporation Pune MAHARASHTRA 411044 India  Phone     Fax     Email  spatsute@yahoo.com
Details Contact Person Scientific Query	Name  Dr Pawan Kumar Singh  Address  Sagar Complex, Opposite Kasarwadi Railway Station, Near Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034, India Pune MAHARASHTRA 411034 India  Phone  9409616256   Fax     Email  pawan.singh@bvglife.com
Details Contact Person Public Query	Name  Dr Pawan Kumar Singh  Address  Sagar Complex, Opposite Kasarwadi Railway Station, Near Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034, India Pune MAHARASHTRA 411034 India  Phone  9409616256   Fax     Email  pawan.singh@bvglife.com
Source of Monetary or Material Support	BVG Life Sciences Ltd. (BVG Group)
Primary Sponsor	Name  BVG Life Sciences Ltd BVG Group  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   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Patsute Sudhir Dadaram  Naidu Hospital, Infectious Diseases Centre.   Behind Pune Main Railway station, off, Wellesley Rd, 411001 Pune   9409616256 spatsute@yahoo.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 2   Name of Committee  Approval Status  Royal Pune Independent Ethics Commitee  Approved  Royal Pune Independent Ethics Commitee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  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 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  SARS-CoV-2 positive nasopharyngeal swab Mild to Moderately severe disease (NEWS score ≤ 8) Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations
ExclusionCriteria	Details  Requiring ICU admission at screening History of MI, Epileptic episodes Any other comorbidity which is at critical stage at screening Any other condition by which subject proves unfit from investigator perspective
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Case Record Numbers
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  No. of days for negative PCR confirmatory test from nasopharyngeal swab for SARS-Covid 2 Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG  From baseline to end of study ie 10 days
Secondary Outcome Modification(s)	Outcome  TimePoints  Clinical status of severity Change in National Early Warning Score Hematological parameters like WBS, RBC and platelet count etc. Change in clinical symptom presentation No. of days for negative PCR confirmatory test for SARS-Covid 2 Requirement of admission to intensive care unit Duration of hospital admission Total days admitted to the hospital  From baseline to end of study ie 10 days
Target Sample Size	Total Sample Size="60" Sample Size from India="60"
Phase of Trial	Phase 1/ Phase 2
Date of First Enrollment (India)	01/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Nil
Brief Summary Modification(s)	Study Summary ShatPlus is a FDA approved Ayurvedic proprietary formulation, made with various standardized herbal actives. A clinical trial was completed on 60 subjects (excluding the dropouts) with mild to moderate symptoms of COVID-19. The key outcomes of the study are: - ShatPlus treatment showed control over disease progression and escalation from mild to severe stage, earlier recovery, and decline in number of days of hospitalization. - There was improvement in the SpO2 levels and clinical symptoms status of the subjects in ShatPlus treatment group and there was no need of supplemental O2 and ICU admission. - At day 4, 73.3% subjects recovered in ShatPlus treatment group, compared to 43.3% in Standard Treatment Group. There was 69.2% more recovery in ShatPlus Treatment group in comparison to Standard Treatment group. - At day 7, 96.7% subjects became negative in ShatPlus Treatment group, compared to 66.7% in Standard Treatment Group. - At day 10, all the subjects became negative in ShatPlus Treatment group, while as in the Standard Treatment Group sizable numbers of subjects were positive even after 10 days. - ShatPlus has demonstrated immunomodulatory activity. - There were no adverse events. - ShatPlus as adjuvant therapy was found to be safe and effective choice in the management of subjects having mild to moderate clinical symptoms of COVID-19 illness.