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Oral VIRAHALT (Novel Immunomodulatory Herbal combination) Compared to standard of care in Subjects with Moderate to Severe COVID-19

An Open-label, Prospective, Randomized, Clinical Trial to Compare the Efficacy and Safety of VIRAHALT® Plus Standard of Care with Standard of Care Alone for the Treatment of Moderate to Severe COVID-19 Infection - VIRA 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028133
Enrollment
60
Registered
2020-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: VIRAHALT plus Standard of Care (SOC): Oral VIRAHALT (Immunomodulatory Herbal combination) plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Governm

Sponsors

LK Wellness
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with laboratory-confirmed (PCR) COVID-19 infection 2. Patients with moderate to severe COVID-19 infection (Early warning score >=5) 3. Hospitalized patients in clinical centres 4. Patients with radiology-confirmed pneumonia within the clinical condition of COVID-19 infection including pulmonary opacity 5. Patients with a clinical indication for pneumonia: increased body temperature (defined as a value above >= 36.6�C axillary route, >= 37.2°C oral route or >= 37.8 °C rectal route), dyspnoea, cough and SpO2 6. Patients aged >=18 years, both genders 7. Patients or LAR able and willing to understand the study, adhere to all study procedures and sign a written Informed Consent Form (ICF) prior to entering the study or with the assistance of the witness

Exclusion criteria

Exclusion criteria: 1. Patients not COVID-19 PCR positive 2. Patients with mild COVID-19 infection 3. Patients who are study subjects in another clinical study for another investigational agent for COVID-19 4. Patients with malignant disease and who are treated for malignant diseases in the last 5 years 5. Patients with severe liver and kidney insufficiency (Hepatic enzymes (AST, ALT, ALP): 6. More than three times normal at baseline will be excluded. Bilirubin: More than 2 at baseline will be excluded. GFR: Less than 60 at baseline will be excluded) 7. Patients who are receiving therapy with another experimental immunomodulatory or immunosuppressive agent 8. Patients aged 9. Known allergy to study nutraceutical or any component thereof

Design outcomes

Primary

MeasureTime frame
Primary: Time to onset of change in the patients clinical condition Safety and tolerability evaluation Secondary: Length of in-hospital stay Survival rate All-Cause Mortality Intubation rate Proinflammatory markers levels Timepoint: Enrolment Day 3 Day 7 Day 14 Day 21—

Secondary

MeasureTime frame
Secondary: Length of in-hospital stay Survival rate All-Cause Mortality Intubation rate Proinflammatory markers levelsTimepoint: Enrolment Day 3 Day 7 Day 14 Day 21—

Countries

India

Contacts

Public ContactDr Padmanaban KG

LK Wellness

pady72@rediffmail.com9008445984

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026