Abstract
BACKGROUND: Traditional knowledge and scientific shreds of evidence strongly support the repurpose of Kalmegh (Andrographis paniculata, CIM-MEG19) as an alternate therapy for prophylactic management and treatment of severe acute respiratory syndrome coronavirus (SARS-CoV) and associated health disorders. PURPOSE: The study aimed to assess the efficacy and safety of the CIM-MEG19 (standardized A. paniculata extract formulation), a proprietary Ayurvedic medicine in the COVID-19 management, clinical recovery, and outcomes in terms of hospitalization days as well as any sign of severity due to drug-drug interaction between CIM-MEG19 (TM) and standard of care (SoC). METHODS: A randomized, parallel-group, active-controlled interventional pilot clinical study was conducted. The Group-A subjects were assigned to CIM-MEG19 add-on to SoC treatment using modern medicine without antiviral drug whereas Group-B patients with SoC treatment using modern medicine and recommended antiviral drug for COVID-19 management. Eighty RTPCR (real-time polymerase chain reaction) positive and eligible COVID-19 patients of age >18 years, having mild or moderate severity, were enrolled. RESULTS: Clinical improvement in reduction of symptoms showed significant (p<0.0001) results in the average days in subjects of group-A (Investigational intervention arm) compared to Group B (SoC). The RT-PCR investigation exhibited COVID negative for 50 % in CIM-MEG19 add-on and 47% in SoC treatment after 8-11 days. Similarly, biochemical investigations showed that CIM-MEG19 group-A had a significant (p ≤ 0.05) effect on C-Reactive Protein (CRP) and Interleukin-6 (IL-6) after 14 days of treatment. Additionally, improvement in D-Dimer, ESR, and LDH in CIM-MEG19 add-on therapy was also observed. CONCLUSIONS: The study demonstrated an excellent safety profile, declining the severity of the infection and halting the disease advancement/progression. CIM-Meg19 might be used as a potential natural drug for treating COVID-19.