Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: ZingiVir H: It is a poly herbomineral drug.Therapeutic dose:
ONE tablet (500 mg) each consumed once in 3 hours ±1 hour between 6 AM and 9 PM in a given day (6AM, 9AM, 12Noon, 3PM, 6P
Sponsors
Pankajakasthuri herbal research foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes aged from 18 years to 60 years old. Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures 3. Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours before randomization 4. Currently hospitalized and requiring medical care for COVID-19 5. Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening 6. Radiographic evidence of pulmonary infiltrates
Exclusion criteria
Exclusion criteria: Candidates for the study will be excluded if ANY of the following criteria are present: 1. Subject or Authorized Representative is unable to provide informed consent 2. Subject is pregnant or breastfeeding ladies 3. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital 4. Subject is 5. Subject has a known allergy to herbal compounds or ZingiVir-H or any components of the drug product 6. Subject has had previous treatment with ZingiVir-H 7. Body weight >= 175 kg 8. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing impairment of hemostasis as a result of one of these procedures 9. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding. 10. Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system or melena, hematemesis. 11. Inability to take oral medication 12. Prolonged QTc-interval in baseline ECG ( >500 ms) 13. History of solid organ, allogeneic bone marrow, or stem cell transplantation. 14. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis 15. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period. 16. Participation in another research study involving an investigational agent within 30 days prior to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 15 [Time Frame: Day 15 from the day of study inclusion]. The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. Timepoint: Baseline ,Day 7 and Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| To find out the anti pyretic activity of ZingiVir HTimepoint: During the therapy. | — |
Countries
India
Contacts
Public ContactDrJHareendran Nair
Pankajakasthuri Herbal research Foundation
Outcome results
None listed