A clinical trial to know the effect of Virulina® along with standard treatment in covid 19 positive patients.

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/06/025556
• Lead Sponsor: Natural Solutions

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-15
• Study Completion: 2020-08-21
• Last Update Posted: 2021-01-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Either male or female of age range 18-70 years.
• 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.

Exclusion Criteria

• Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	Day 1, Day 7 and Day 14
Time point-Up to 14 days	Day 1, Day 7 and Day 14
- 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 Measures

Name	Time	Method
Improvement in the clinical lab variables	Subject global assessment of symptoms

Trial Locations

Locations (1)

Government Medical college & Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Government Medical college & Government General Hospital

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr A Gopal Rao

Principal investigator

9440122790

drgopalraoa@gmail.com