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CTRI Number  CTRI/2020/09/028158 [Registered on: 30/09/2020] Trial Registered Prospectively
Last Modified On: 15/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  		 Ayurvedic Proprietary Medicine (VIRANORM) clinical trial on COVID-19 patients 
Scientific Title of Study
Modification(s)  		 A clinical study to evaluate the role of Herbal Immunomodulator (VIRANORM) as an add on treatment in Asymptomatic and mildly symptomatic covid-19 confirmed cases. 
Trial Acronym  VIRA 2 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Padmanaban KG  
Designation  Senior Consultant Ayurvedic Physician  
Affiliation  LK Wellness  
Address  LK Wellness #75 3rd Cross Residency Road Next to Ballal Residency, Bengaluru,

Bangalore
KARNATAKA
560025
India 
Phone  9008445984   
Fax    
Email  pady72@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padmanaban KG  
Designation  Senior Consultant Ayurvedic Physician  
Affiliation  LK Wellness  
Address  LK Wellness #75 3rd Cross Residency Road Next to Ballal Residency, Bengaluru,


KARNATAKA
560025
India 
Phone  9008445984   
Fax    
Email  pady72@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Padmanaban KG  
Designation  Senior Consultant Ayurvedic Physician  
Affiliation  LK Wellness  
Address  LK Wellness #75 3rd Cross Residency Road Next to Ballal Residency, Bengaluru,


KARNATAKA
560025
India 
Phone  9008445984   
Fax    
Email  pady72@rediffmail.com  
 
Source of Monetary or Material Support  
LK Wellness 75 3rd Cross Residency Road Next to Ballal Residency, Bengaluru, 560025 
 
Primary Sponsor  
Name  LK Wellness  
Address  75 3rd Cross Residency Road Next to Ballal Residency, Bengaluru, 560025  
Type of Sponsor  Other [Nutraceutical and Ayurvedic] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrCR Jayanthi  Bangalore Medical College and Research Institute  Bangalore Medical College and Research Institute Fort, Krishna Rajendra Rd, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9448292424

bmccrj@gmail.com 
Dr V Channaraya   Cura Hospital   Room No. 004 Department of General Medicine No. 18. Kanakpura Road Venkattareddy Layout. Industrial Area. Doddakallasandra Uttarahalli Hobli Bangalore. 560062
Bangalore
KARNATAKA 		 9341234049

vcraya@yahoo.com 
DrMK Sridhar  Kusuma hospital   No.237/37, Nagendra Block, 50ft Road, 10th Main Rd, Srinagar, Banashankari, Bengaluru, Karnataka 560050
Bangalore
KARNATAKA 		 9886597246

sridharmk.mbbs@gmail.com 
Dr Sridhar MK   Maiya Multispeciality Hospital  Department of Internal Medicine 34, 10th Main Rd, 1st Block, Jayanagar 1st Block, Jayanagar Bengaluru, Karnataka 560011
Bangalore
KARNATAKA 		 9886597246

sridharmk.mbbs@gmail.com 
Dr S Poorna Prasad  Shetty’s Hospital   Department of Internal Medicine Plot No. 11,12. 12th F Main Road. Kaveri Nagar. Kodichikkanahalli. Bommannahalli. Bangalore. 560068 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9164245208

spoornaprasad250@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College and Research Institute  Approved 
Shettys Hospital Ethics Committee (Cura Hospital)   Approved 
Shettys Hospital Ethics Committee (Kusuma Hospital)  Approved 
Shettys Hospital Ethics Committee (Maiya Multispeciality Hospital)   Approved 
Shettys Hospital Ethics Committee (Mallige Hospital)  Approved 
Shettys Hospital Ethics Committee (Shettys Hospital)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Placebo plus Standard of Care (SOC)   Placebo plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020) Duration of Placebo: 21 days. The Standard of care (SOC) will be provided as per the current COVID-19 guidelines (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020). Duration: Standard of care to be continued as decided by the principal investigator. 
Intervention  VIRANORM plus Standard of Care (SOC)   Oral VIRANORM (Ayurvedic Proprietary Medicine) plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020) Route of administration - Oral. VIRANORM Dose - 1 Capsule every 6 hours. Duration of VIRANORM treatment: 21 days. The Standard of care (SOC) will be provided as per the current COVID-19 guidelines (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020). Duration: Standard of care to be continued as decided by the principal investigator.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Must be ≥18 years and ≤70 years at the time of signing the informed consent
2. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures
3. Able to adhere to the study visit schedule and other protocol requirements
4. Asymptomatic or Mild Symptomatic PCR positive COVID-19 infection with outpatient/in-patient management as decided by the treating physician
5. Early warning score for 2019-nCoV infected patients < 5
6. Females of childbearing potential must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
7. Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
 
 
ExclusionCriteria 
Details  1. Requirement for oxygen administration
2. Shortness of breath in resting position
3. Creatinine > 2.0 mg/dl
4. Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
5. Women during pregnancy and lactation
6. Participation in other clinical trials or observation period of competing trials
7. Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
8. Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
9. Physician decision that involvement in the study is not in the patient´s best interest
10. History of alcohol or drug abuse in the previous two years.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in disease manifestation in asymptomatic patients
Difference in time to resolution of clinical signs and symptoms of mild COVID-19
Proportion of patients with negative COVID-19 PCR test at day 21 in per protocol population
Difference between VIRANORM - and placebo treated patients on an ordinal outcome scale until Day 21 (death, admission to intensive care, hospitalization, duration of hospitalization, continuing disease, recovered)
 		 Enrolment
Day 3
Day 7
Day 14
Day 21
 
 
Secondary Outcome  
Outcome  TimePoints 
COVID-19 antibodies and clinical immunological markers   Day 14
Day 21 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/10/2020 
Date of Study Completion (India) Date Missing 
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)  		 It is anticipated that the results of this study may be presented at scientific meetings and/or published in a peer reviewed scientific or medical journal. Current guidelines and recommendations on good publication practice will be followed  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		  
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