Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Asymptomatic, Mild to moderate cases registered in A & U, Tibia hospital above 18-60 years of age, with COVID 2019 (Confirmed by RT-PCR or Rapid Antigen Test) quarantined at identified hospital set up.
2.Participants who can take medicines orally
3.Patients willing to provide signed informed consent
1.Cases of severe vomiting which would make oral administration of medicine difficult.
2.Cases of respiratory failure and requiring mechanical ventilation.
3.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal.
4.Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation
5.Pregnant or lactating women
6.Any other condition, which as per the investigator would jeopardize the outcome of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test. <br/ ><br>2. Changes in liver enzymes, Renal functionsTimepoint: 1.Negative status of SARS-CoV-2 on nasal or throat swab after 07 days or 14 days of intervention in a 2 day continuous real time RT-PCR test. <br/ ><br> <br/ ><br>[Time frame: 8th day or 15th day] <br/ ><br> <br/ ><br>2. Changes in liver enzymes, Renal functions [Time frame: 8th day or 15th day]
- Secondary Outcome Measures
Name Time Method 1.Mean time (days) for clinical recovery as per clinical recovery criteria defined. <br/ ><br>2.Number of symptomatic patients showing â??clinical recoveryâ??. <br/ ><br>Improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG).Timepoint: 1.Mean time (days) for clinical recovery as per clinical recovery criteria defined. <br/ ><br>[time frame:7th day,14th day if RTPCR positive-on 8th or 9th Day] <br/ ><br>Time frame: 8th day or 15th day <br/ ><br>2.Time frame: 8th day (after intervention of 7 days) or 15th day( in case intervention for 14 days).