Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Ganjhuvir Syrup: 10 ml Ganjhuvir syrup will be administered 3 times a day, 1 hr before meal, along with SOC for 10 days
Intervention2: Ganjhuvir Tablet: 1 Ganjhuvir Tablet will be admin
Sponsors
Radhika Ayurveda Research and Development
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female volunteers aged between 18 to 65 years both inclusive. 2. Ready to give informed volunteer consent. 3. Respiratory Syndrome caused by Corona virus infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests. 4. Patient who require hospitalization. 5. Diabetic patients with sugar levels in normal limits. 6. Females must be using an effective contraception method or other form of birth control prior to and during the study and use will continue till EOS. 7. Males will ensure that their female partners of childbearing potential will utilize an effective contraceptive method or other form of birth control to avoid pregnancy.
Exclusion criteria
Exclusion criteria: 1.Previously treated with antiviral therapy, systemic steroids or immunosuppressant within 2 weeks prior to study Day1. 2. Participation in any other clinical trial of an experimental treatment for Covid-19 or any other clinical trial of different indication. 3. Hospitalization in ICU. 4. Evidence of multiorgan failure, suspected latent tuberculosis infection 5. Requiring mechanical ventilation at screening. 6. Any known severe allergic/ hypersensitivity to GanjhuVir syrup or tablet. 7. Patients with chronic kidney disease, cardiac anomaly, receiving cancer therapy, HIV positive or Hepatitis positive. 8. Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or lactating. 9. Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in thisstudy. 10. Participation in another trial with an investigational drug within 1 month prior to this trial. 11. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in Covid -19 viral load on day 5 and day10. 2. Improvement in symptoms like cough, sore throat, fever, inflammation and shortness of breath from baseline to 5 and day10 3. Changes in platelet, WBC count and C- Reactive Protein from baseline to day 5, and up to10 4. Number of patients requiring oxygen therapy at the end of the treatment[10 day] 5. Temperature measurement twice daily at armpit [9 AM and 9PM] 7Duration of hospitalization: From randomization up to day10. Timepoint: Efficacy Assessments from day 0 to day10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate safety of GanjhuVir syrup and Tablet in Covid-19 positive patients.Timepoint: 1. Safety assessments from day 1 to day 14 | — |
Countries
India
Contacts
Public ContactDr Rajesh Kumar Ganjhu
Radhika Ayurveda Research and Development
Outcome results
None listed