Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Vasa Ghana (Aqueous extract of Adhatoda
vasica),:
The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test
positive will be administered Vasa Ghana (whole water soluble extra
Sponsors
Ministry of AYUSH Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or mild symptoms Voluntariness to participate in the trial Patients who are able to take the drug orally and comply with study procedures. Women of childbearing potential must have a negative urine pregnancy test prior to study entry. Age 19-65 years
Exclusion criteria
Exclusion criteria: COVID patients with symptoms classified as moderate, severe or critical. Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria: Respiratory distress at room ambience (>=30 breaths per min) SaO2/ SpO2 than one hour to normalize. PaO2/ FiO2 Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for more than 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. (Adapted and modified from the reference: Yang Liu et al. Lancet Infect Dis 2020, 2020 https://doi.org/10.1016/ S1473-3099(20)30232-2) Individuals with uncontrolled, unstable co-morbidities/ co-existent medical illness such as diabetes, hypertension, cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern that may put the patient at increased risk during the study. Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc. and who are considered to be excluded from the study as evaluated by the investigators. Individuals with pre-existing respiratory conditions Immuno-compromised individuals or those on immune suppressants. History of immune suppression: solid organ or bone marrow transplant, use of immune suppressive anti-metabolic and biologic agents, intrinsic immune deficiencies, HIV infection. Patients on or requiring parenteral nutrition Patients with known sensitivity or contraindication to any of the study medication. Pregnant and lactating females Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. Physician decision that involvement in the study is not in the patient´s best interest. Patient with persistent vomiting more than three episodes of vomiting in 12 hours, preventing adequate oral hydration. Patient with known active hepatitis, and definite bacterial or fungal infections. Patient with altered mental state. Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration. Patient with history of evidence of chronic interstitial infiltration at imaging. Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immune deficiency virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of time to clinical improvement/disease progression Duration of fever and respiratory symptoms Incidence of respiratory failure Number of days of treatment and hospitalization Requirement of SOS medication- reason and no.of times Requirement of Rescue medication Percent mortality Adverse events Percent mortality Changes in all the Lab parametersTimepoint: Length of time to clinical improvement/disease progression Duration of fever and respiratory symptoms Incidence of respiratory failure Number of days of treatment and hospitalization Requirement of SOS medication- reason and no.of times Requirement of Rescue medication Percent mortality Adverse events Percent mortality Changes in all the Lab parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of time to clinical improvement/disease progression Duration of fever and respiratory symptoms Incidence of respiratory failure Number of days of treatment and hospitalization Requirement of SOS medication- reason and no.of times Requirement of Rescue medication Percent mortality Adverse events Percent mortality Changes in all the Lab parametersTimepoint: (days from admission; days from first testing positive; days from first noticed symptoms) | — |
Countries
India
Contacts
Public ContactDr Meera K Bhojani
CSIRâ??s Ayurgenomics Unit- IGIB
Outcome results
None listed