Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Vedicinals-9 along with standard care: Vedicinals-9-Active (9 compounds) 5000 mg in Additive 50 ml suspension per day [100 mg/ml suspension] Loading dose on day 1 - 25 ml each at 1 hour
Sponsors
Vedicinals India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals of either sex above 18 and below 60 years of age 2. Individuals who have been tested positive to be infected with SARS-COV2 Virus and presenting with no symptoms or mild to moderate symptoms. 3. Voluntariness to participate in the trial and give signed informed consent.
Exclusion criteria
Exclusion criteria: 1. COVID-19 Patients with symptoms classified as severe or critical 2. Individuals with uncontrolled, unstable comorbidities as evaluated by the investigators. 3. Individuals with preexisting respiratory conditions, severe primary respiratory disease or pneumonia. 4. Immuno-compromised Individuals or those on immunosuppressant 5. Patients on or requiring parenteral nutrition/care. 6. Pregnant/lactating women. 7. COVID-19 positive individuals participating in the interventional arm of other COVID-19 clinical trial. 8. Individuals with serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease. 9. Subjects with alcohol and/or substance dependence. 10. Subjects with known allergic reactions to any other herbal supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Percentage of COVID-19 patients and time taken to get COVID-19 RT-PCR negative b) Time of convalescence and improvement in altered biomarkers post COVID-19 infectionTimepoint: a) Days from admission, days from first testing positive, days from first noticed symptoms b) At screening, day 5, day 12 and day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Arrest or delay in progression of asymptomatic symptoms to mild or moderate to severe to critical.Timepoint: Days from admission, days from first testing positive, days from first noticed symptoms;Change in the Patient reported score of each of the 7 influenza symptoms â?? cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue.Timepoint: Screening, day 1, day 5, day 12 and day 45;Days of treatment and hospitalizationTimepoint: From day 1 to end of study;Incidence of respiratory failure and requirement of rescue medicationTimepoint: Throughout the study period;Percent MortalityTimepoint: End of the study;Time to allaying a feverTimepoint: Days from admission, days from first testing positive, days from first noticed symptoms;Time to symptom reliefTimepoint: Days from admission, days from first testing positive, days from first noticed symptoms | — |
Countries
India
Contacts
Public ContactYogendra Kumar Choudhary
Ethix Pharma
Outcome results
None listed