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CTRI Number  CTRI/2020/04/024659 [Registered on: 15/04/2020] Trial Registered Prospectively
Last Modified On: 02/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Trial 
Public Title of Study   Study of Shreepad Shree Vallabh SSV Formulation to improve immunity in quarantine patients of COVID-19 
Scientific Title of Study   An open labelled trial to evaluate safety and efficacy of SSV Formulation to boost immunity in quarantine patients of COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No. SSV-SF-04/2020, Version 1, dated 08th Apr 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samadhan Patil 
Designation  Medical Officer 
Affiliation  Niphad Sub district Hospital 
Address  Department of Medicine, Niphad Sub district Hospital, Niphad, Maharashtra, India

Nashik
MAHARASHTRA
422303
India 
Phone  91-9421520666  
Fax    
Email  medicalsuperintendent.niphad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh Dound 
Designation  Proprietor 
Affiliation  Shreepad Shree Vallabh SSV Phytopharmaceuticals 
Address  201/2, Old Kashmiri Building, R. R. Thakur Marg, Majas Wadi, Jogeshwari (E) Mumbai

Mumbai
MAHARASHTRA
400060
India 
Phone  91-9769057549  
Fax    
Email  yogesh_dound@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Samadhan Patil 
Designation  Medical Officer 
Affiliation  Niphad Sub district Hospital 
Address  Department of Medicine, Niphad Sub district Hospital, Niphad, Maharashtra, India

Nashik
MAHARASHTRA
422303
India 
Phone    
Fax    
Email  medicalsuperintendent.niphad@gmail.com  
 
Source of Monetary or Material Support  
SSV Phytopharmaceuticals, 201/2, Old Kashmiri Building, R. R. Thakur Marg, Majas Wadi, Jogeshwari (E) Mumbai-400 060 
 
Primary Sponsor  
Name  SSV Phytopharmaceuticals 
Address  201/2, Old Kashmiri Building, R. R. Thakur Marg, Majas Wadi, Jogeshwari (E) Mumbai-400 060 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Samadhan Patil  Niphad Sub district Hospital  Department of Medicine, Nandurdi Rd, Niphad. 422303
Nashik
MAHARASHTRA 
02550241288

medicalsuperintendent.niphad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nav Sanjeevani Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B342||Coronavirus infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  SSV Formulation Tablets  Each tablet of 500 mg to be consumed orally twice a day immediately after meals for 15 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Recent history of contact with COVID-19 positive people and are advised to be quarantined or has symptoms which include cough, fever with or without chills and difficulty in breathing.
2. Willing to provide informed consent. 
 
ExclusionCriteria 
Details  1. Presence of acute hypoxic respiratory failure.
2. Intensive care unit (ICU) stay.
3. Patients who need mechanical ventilation.
4. Category 6 or 5 based on modified 7-category ordinal scale of clinical status. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in ambulatory patients who are assessed daily for symptoms which include cough, fever with or without chills and difficulty in breathing for the period they are in quarantine.

 
Baseline, telephonically everyday and day 15. 
 
Secondary Outcome  
Outcome  TimePoints 
The ambulatory patients who did not require artificial ventilation or were not admitted to ICU during the period of quarantine. Improvement in the clinical variables including Pro inflammatory cytokine IL-6 from baseline to end of the quarantine period i.e. 15 days.  Baseline, telephonically everyday and day 15. Clinical variables including Pro inflammatory cytokine IL-6 will be recorded at baseline and at day 15.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/04/2020 
Date of Study Completion (India) 28/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Sent for Publication. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
The primary objective of the study is to evaluate the role of SSV Formulation to boost immunity in quarantined patients of COVID-19 as judged by the improvement in signs such as axillary temperature, respiratory rate, pulse, blood pressure and symptoms which include cough, fever with or without chills and difficulty in breathing with Visual Analog Scale (VAS) score for cough and respiratory distress and globally validated SF-36 Questionnaire.  

Secondary objective of the study is Safety and tolerability; clinical variables including Pro inflammatory cytokine IL-6. 

N=30
 
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