Ayurvedic Rasayana treatment as an addon therapy to improve the results in management of coronavirus disease

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations

• Registration Number: CTRI/2020/07/026343
• Lead Sponsor: Ayurved Rasayani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021
• Study Completion: 2021-12-23

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1 Age 18 to 60 years

2 COVID-19 positive as determined by PCR or other approved commercial or public health assay

3 Willing and able to provide written informed consent prior to performing study procedures

Exclusion Criteria

1 Participation in any other clinical trial of an experimental treatment for COVID 19

2 Patients with severe COVID 19 disease defined as follows

3 Respiratory distress as determined by >=30 breaths per min

oxygen saturation at rest <=85%

Severe disease complications e g respiratory failure requirement of mechanical ventilation, septic shock or non-respiratory organ failure

4 Patients with deranged liver functions i.e Total bilirubin <= 2 Liver enzymes <=2.5 times Under Normal limits or deranged renal functions i.e Creatinine <= 1.5 times Under Normal limits

5 Patients with unstable angina or history of Myocardial infarction or underwent CABG

6 Patients with known diagnosis of COPD

7 Pregnant women or women who are breastfeeding

Immunocompromised patients or patients taking immunosuppressant medication or Patients with active malignancy Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of patients progressed to severe stage. <br/ ><br> <br/ ><br>Severe stage defined as <br/ ><br>â?¢respiratory distress (â?¥30 breaths per min); <br/ ><br>â?¢oxygen saturation at rest â?¤85%; <br/ ><br>â?¢severe disease complications (eg, respiratory failure, requirement of mechanical ventilation, septic shock, or non-respiratory organ failure). <br/ ><br> <br/ ><br>Timepoint: Day 0 <br/ ><br>Till day 10

Secondary Outcome Measures

Name	Time	Method
Evaluation of Pro inflammatory cytokines. <br/ ><br>Disease severity on an ordinal scale. <br/ ><br>Length of time to clinical improvement and clinical progression <br/ ><br>Evaluation of D-dimer <br/ ><br>Length of time to normalization of fever, normalization of oxygen <br/ ><br>Duration of supplemental oxygen and /mechanical ventilation <br/ ><br>Number of participants that developed ARDS <br/ ><br>Duration required to get COVID-19 PCR test negative <br/ ><br>Duration of hospitalization /or ICU stay <br/ ><br>Percent mortality <br/ ><br>Timepoint: Till day 10