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CTRI Number  CTRI/2020/06/025556 [Registered on: 02/06/2020] Trial Registered Prospectively
Last Modified On: 01/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to know the effect of Virulina® along with standard treatment in covid 19 positive patients. 
Scientific Title of Study   A double blind, placebo controlled, randomized clinical trial to evaluate the efficacy and safety of the Virulina® along with standard treatment as per hospital protocol for the treatment of novel coronavirus (COVID-19). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PHAR/CT/VIRULINA/COVID/10052020 Version 01 dated 11 May 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Gopal Rao 
Designation  Associate Professor of Medicine 
Affiliation  Government Medical College & Govt. General Hospital 
Address  Dept of Internal medicine Government Medical College Govt General Hospital Old RIMSGGH Srikakulam

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  9440122790  
Fax    
Email  drgopalraoa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Baburao Vikram 
Designation  Managing Director 
Affiliation  Pharexcel Consulting 
Address  Pharexcel Consulting Clinical Research Dept. Clinical Operations section Plot No. 11 10th Cross AYR lay out Shettyhalli Jalahalli West Bengaluru

Bangalore
KARNATAKA
560015
India 
Phone  9878551428  
Fax    
Email  info@pharexcelconsulting.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Sharma 
Designation  Director 
Affiliation  Natural Solutions 
Address  Natural solutions Dept. of Internal medicine Ayurvedic section Anjani complex B 14 Pereira Hill Road Off A K Road Near Western Express Metro Station Gate No 7 Andheri East Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  9831071188  
Fax    
Email  dranil1965@gmail.com  
 
Source of Monetary or Material Support  
Natural Solutions Anjani complex, B 14, Pereira Hill Road, Off A. K. Road, Near Western Express Metro Station Gate No 7 Andheri East, Mumbai 400093 
 
Primary Sponsor  
Name  Natural Solutions 
Address  Anjani complex, B 14, Pereira Hill Road, Off A. K. Road, Near Western Express Metro Station Gate No 7 Andheri East, Mumbai 400093 
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 A Gopal Rao  Government Medical college & Government General Hospital  Government Medical college & Government General Hospital, Dept. of general medicine, Room no 13, First floor, Shanti Nagar Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH 
9440122790

drgopalraoa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 along with standard treatment protocol  Dose: 3gm, three times a day Dosage form: Powder Route of Administration: Oral Time of Administration: morning, afternoon and evening Duration of treatment: 14 days  
Intervention  Virulina® along with standard treatment protocol  Dose: 3gm, three times a day Dosage form: Powder Route of Administration: Oral Time of Administration: morning, afternoon and evening Duration of treatment: 14 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Either male or female of age range 18-70 years.
2. 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 (Time interval between symptoms onset and randomization to be not more than 7 days)
3. Patients with laboratory confirmation of infection with SAARS-CoV-2 by positive RT-PCR (within 48 hrs prior to randomization)
Subjects willing to give written informed consent and come for a regular follow up
4. Subjects willing to abide by and comply with the study protocol
 
 
ExclusionCriteria 
Details  1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
2. Presence of acute hypoxic respiratory failure
3. Requires Intensive care unit (ICU) care for management of ongoing clinical status
4. Severe infection, defined as need for invasive or non- invasive ventilator support
5. Inability to intake or tolerate oral medication
6. Category 6 or 5 based on modified 7-category ordinal
scale of clinical status
7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission
8. Pregnant subjects 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time until cessation of oral shedding of SAARS-CoV- 2 virus (Time in days from randomization to a negative SAARS-Cov-2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab).
Time point-Up to 14 days
- Clinical cure based on Clinician’s assessment of symptoms which include cough relief, recovery from fever and difficulty in breathing for the period they are in quarantine. (For those patients who presented with clinical signs and symptoms at baseline).  
Day 1, Day 7 and Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the clinical lab variables
Subject global assessment of symptoms
Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
Necessity of invasive assisted ventilation
Necessity of non-invasive assisted ventilation
Intensive care unit admission
Post-anesthesia care unit admission
Hospital admission
Medical consultation
Home care and isolation time
Bed rest time
symptoms duration 
Day 1, Day 7 and Day 14. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2020 
Date of Study Completion (India) 21/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The Virulina® formulation has been formulated after extensive literature survey on the Indian medicinal plants and their reported traditional use and applications in reference herbal text books and formularies, and also based on past experimental data reported on pharmacological activities relevant to antiviral and immunomodulator activities. Its components have shown activity against HIV-1 and HSV-1 & 2 viruses. 

The Jin Yintan Hospital in Wuhan, China, where the first 41 known patients were treated, has already launched a randomized, controlled trial of the anti-HIV drug combination of lopinavir and ritonavir, according to a 24 January report by a group of Chinese scientists in The Lancet. The combination targets protease, an enzyme used by both HIV and coronavirus to cut up proteins when they make new copies of themselves. A study published in 2004 showed that the combination showed “substantial clinical benefit” when given to patients who had severe acute respiratory syndrome (SARS), which is caused by a coronavirus similar to novel coronavirus-2019.

Given the circumstances with the Covid-19, where the treatments are still underway, an agent like Virulina® which has antiviral as well as immunomodulator activity definitely stand a chance. Virulina® is a polyherbal compound and can produce synergistic anti-viral effect, which might provide some aid in the treatment and prevention of novel coronavirus (Covid- 19) as well as improve the overall condition of existing patients with its immuno-stimulant activity.

Risk / Benefit Assessment

Non clinical studies did not reveal any potent risk associated with this formulation. Also owing to its immunomodulator and antiviral activities it might boost the immunity of the patients and help ease the symptoms.

Virulina Composition: 

Each 3 gm of poweder contains Triphala (Amla, Harde & Baheda)- 50 mg, Daruharidra- 50mg, Kantakari Root- 100 mg, Trikatu  (Sunthi, Maricha, Pippali)- 100 mg, Moorba Whole-50mg Guduchi-100 mg, Jawasa-50 mg, Kutaki-50 mg Trayamana-50 mg, Sugandhbala-50 mg, Neem Chaal-100 mg, Mulethi-50 mg, Kuda chhal-100 mg, Ajwain-50 mg, Bharangi-100 mg, Sahijn beej-50mg, Swertia chireta-50 mg, Vacha(Bal) -50 mg, Chitrak-50 mg, Devdaru-50 mg, Chavya-50 mg, Patolpatra-50 mg, Kalmegh-100 mg, Lavang-100 mg, Kamal (flower & rhizomes)-100 mg, Kakoli (tuber root)- 50 mg, Tejpatra-50 mg, Talispatra-50 mg, Javitri-50 mg, Ativisha- 100 mg, Haldi-50 mg, Dalchini-50 mg, Khas Khas-50 mg, Shwet Chandan-50 mg, Khareti-50 mg, Shaliparni-100 mg and Prishniparni100 mg

 
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