| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |