Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Capsule. AEV01 100 mg: AEV01 is a root extract of Kutki (Picrorhizakurroa 100 mg)
Given thrice daily orally after food for 30 days
Control Intervention1: Placebo capsule: Placebo caps
Sponsors
PM Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to performing study procedures. 2. Adult patients aged more than 50 years with SARS-CoV-2 infection and mild disease. Patients with Mild (uncomplicated) Illness is defined as â?? a.Diagnosed with COVID-19 by a standardized RT-PCR assay AND b.Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND c.No signs of a more serious lower airway disease AND d.RR 94% on room air
Exclusion criteria
Exclusion criteria: 1. Participants with moderate and severe illness of COVID19. 2. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) 3.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR 4.Immuno-compromised patients on medications. 5.Participation in any other clinical trial of an experimental treatment for COVID-19 6. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for clinical improvement , which is defined as; 1. Normalization of pyrexia and body pain 2. Respiratory rate less than 24/minute 3.Spo2 rate greater than 94% 4. Relief from cough and maintenance of above for more than 72 hours. Timepoint: Day 1 to Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale. 2. Change from baseline in the following lab parameters namely, CBC, ESR, RBS, CRP, LFT, RFT, Serum electrolytes, serum ferritin, D-dimer, CD4, CD8, TNF-ï?¡, IL-6, Covid-19 IgM & IgG and HRLCT scan. 3.Change from baseline in National Early Warning Score 4.Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) / SAEs 5.Time to Recovery Timepoint: Day 1 to Day 30 | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
Sri Sai Ram Ayurveda Medical College
Outcome results
None listed