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
|
|
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
|
|
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 |