Efficacy of AYUSH-64 (a polyherbal formulation) in COVID - 19 Cases

Phase 3

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/05/025335
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-08-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 37

Inclusion Criteria

Mild to moderate cases registered in CHC CBPACS above 18 years of age, with COVID 2019 (Confirmed by RT-PCR)

Participants who can take medicines orally

Patients willing to provide signed informed consent

Exclusion Criteria

Cases of severe vomiting which would make oral administration of medicine difficult.

Cases of respiratory failure and requiring mechanical ventilation.

Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal.

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

Pregnant or lactating women

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
a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below <br/ ><br>b) Number of patients showing â??clinical recoveryâ?? <br/ ><br>Timepoint: Baseline <br/ ><br>Day 8 <br/ ><br>Day 15

Secondary Outcome Measures

Name	Time	Method
1.Percentage of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test. <br/ ><br>2.Improvement in selected laboratory parameters:, differential and total leukocyte counts, acute phase reactants, serum IL-6, Serological Protective Antibody Assay (IgE ,IgM and IgG) <br/ ><br>3.Changes in liver enzymes, Renal functions <br/ ><br>4.No of cases Reporting any ADR/AE <br/ ><br>5.Number of participants referred with onset of complications <br/ ><br>Timepoint: Baseline <br/ ><br>8th day <br/ ><br>15th day