Preprint / Version 1

A randomized controlled pilot study of add-on therapy of CIM-MEG19 (standardized Andrographis paniculata formulation) in mild to moderate COVID-19

Authors

  • Karuna Shanker aAnalytical Chemistry, Phytochemistry Division, CSIR-Central Institute of Medicinal and Aromatic Plants (CSIR-CIMAP), Lucknow-226015, India
  • Hrishikesh Rangnekar bQuestt Clinicals and Ayurceuticals, Pune, India
  • Asmita Wele cDepartment of Rasashastra and Bhaishajyakalpana, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Pune-411043, India
  • Pravin Soni dPimpri Chinchwad Municipal Corporation's Postgraduate Institute, Yashwantrao Chavan Memorial Hospital, Pimpri, Pune-411018, India
  • Pranesh Gaikwad ePanchakarma Department, Dr. D. Y. Patil College of Ayurved and Research Centre, Dr. D. Y. Patil Vidyapeeth Pune (Deemed to be University), Pimpri, Pune-411018, India
  • Anirban Pal fBio-Prospection and Product Development Division, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow-226015, India
  • Dnyaneshwar Bawankule aAnalytical Chemistry, Phytochemistry Division, CSIR-Central Institute of Medicinal and Aromatic Plants (CSIR-CIMAP), Lucknow-226015, India
  • Debabrata Chanda fBio-Prospection and Product Development Division, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow-226015, India

Keywords:

Antiviral, SARS-CoV-2, Inflammation, Kalmegh, Ayurvedic pharmacopeia of India, Immunomodulation

Abstract

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. Keywords: Antiviral, SARS-CoV-2, Inflammation, Kalmegh, Ayurvedic pharmacopeia of India, Immunomodulation

Author Biography

Dnyaneshwar Bawankule, aAnalytical Chemistry, Phytochemistry Division, CSIR-Central Institute of Medicinal and Aromatic Plants (CSIR-CIMAP), Lucknow-226015, India

fBio-Prospection and Product Development Division, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow-226015, India

Downloads