Health Condition 1: - Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: CIM-Meg19: Dosage Form: 02 Tablets
Duration : Day 1 to Day 21
Route: Orally twice daily after meal.
Control Intervention1: Standard of care: 1. Patients on Standard care medicines who a
Sponsors
Ms Meghdoot Gramodyog Sewa Sansthan
Council of Scientific and Industrial Research CSIR
Eligibility
Inclusion criteria
Inclusion criteria: a) Age- 35-90 years b) Gender- Male or non-pregnant, non-lactating female patient aged >=35and c) Mild to moderate cases of COVID-19 d) Capable of taking oral drugs e) SpO2 > 93% in room air f) PaO2 /FiO2 : 200-300 g) RR h) No evidence of hypoxemia or breathlessness i) Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection.
Exclusion criteria
Exclusion criteria: a) Patients who are unwilling to participate in the study. b) Patients with known sensitivity to any of the ingredients of the trial drug. c) Presence of acute hypoxic respiratory failure. d) Patients who require ICU stay. e) Patients requiring mechanical ventilation. f) Category 5 or 6 based on modified 7- category ordinal scale of clinical status. g) Any pre-existing GI symptoms like nausea or vomiting. h) Patients suffering from bleeding hemorrhoids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In subjective QOL, using WHO QOLTimepoint: Day 0, 7, 14,21 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of the drug by monitoring for adverse events and laboratory parameters.Timepoint: OUTCOMES TIMELINE RT- PCR of nasal/oropharyngeal swabs Day 0, 7, 14,21 LDH, TLC, CRP, D-DIMER, IL-6 Day 0, 7, 14, 21 Variations in clinical symptoms Day 0, 7, 14, 21 Haemogram, ESR, LFT, RFT, Lipid Profile, Blood Sugar, Urine â??R/M Day 0, 21 | — |
Countries
India
Contacts
Public ContactDr Karuna Shanker
CSIR-CIMAP, Lucknow
Outcome results
None listed