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

Karuna Shanker; Hrishikesh Rangnekar; Asmita Wele; Pravin Soni; Pranesh Gaikwad; Anirban Pal; Dnyaneshwar U Bawankule; Debabrata Chanda

doi:10.1016/j.phyplu.2022.100398

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

Phytomed Plus. 2023 Feb;3(1):100398. doi: 10.1016/j.phyplu.2022.100398. Epub 2022 Dec 20.

Authors

Karuna Shanker¹, Hrishikesh Rangnekar², Asmita Wele³, Pravin Soni⁴, Pranesh Gaikwad⁵, Anirban Pal⁶, Dnyaneshwar U Bawankule^{1

6}, Debabrata Chanda⁶

Affiliations

¹ Analytical Chemistry, Phytochemistry Division, CSIR-Central Institute of Medicinal and Aromatic Plants (CSIR-CIMAP), Lucknow-226015, India.
² Questt Clinicals and Ayurceuticals, Pune, India.
³ Department of Rasashastra and Bhaishajyakalpana, College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Pune-411043, India.
⁴ Pimpri Chinchwad Municipal Corporation's Postgraduate Institute, Yashwantrao Chavan Memorial Hospital, Pimpri, Pune-411018, India.
⁵ Panchakarma 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.
⁶ Bio-Prospection and Product Development Division, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow-226015, India.

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.

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