Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: CIM-Meg19: 02 tablets two times a day after meal to be administered orally.
Control Intervention1: Standard care treatment: Standard care treatment as per siteâ??s routine practice / ph
Sponsors
Ms Meghdoot Gramodyog Sewa Sansthan
Council of Scientific and Industrial Research CSIR
Eligibility
Inclusion criteria
Inclusion criteria: COVID-19 RT-PCR positive patients Male or Female of age 18-70 years Subject is ready to give written Informed consent Can take oral medicines Mild to moderate grade of the disease. Mild- Upper respiratory tract symptoms of fever with or without shortness of breath or hypoxia. Moderate- Any one of- 1. Respiratory rate more than 24/min, breathlessness 2. SpO2: 90-93% on room air. 3. PaO2 /FiO2 : 200-300/g) as per AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group recommendations Not participating in any other interventional drug study g) Agree to follow all study procedures
Exclusion criteria
Exclusion criteria: Known sensitivity to the ingredients of IP Bleeding haemorrhoids Pre-existing GI symptoms like nausea or vomiting Presence of acute hypoxic respiratory failure Intensive care unit (ICU) stay- Patients who need mechanical ventilation Category 6 or 5 based on modified 7-category ordinal scale of clinical status Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely Severe infection Pregnant or lactating women For Arm A: subjects receiving any antiviral treatment for Covid (like Favipiravir, Remdesivir)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. To assess time to 2 point improvement (from time of enrolment) on the WHO ordinal scaleTimepoint: Days- 0, 4, 8 and 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression comparison in both arms Frequency of serious adverse events in both the arms Improvement in oxygen saturation Proportion of RT-PCR negatives on Day 8 day Number of hospital daysas compared to control group Changes in lab investigations on day 4 daysWRT day 0(like inflammatory markers, haemogram etc.) in blood investigations group Timepoint: 0, 8, 14 and 21 days | — |
Countries
India
Contacts
Public ContactDr Karuna Shanker
College of Ayurved, Bharati Vidyapeeth
Outcome results
None listed