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

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

Karuna Shanker  1 , Hrishikesh Rangnekar  2 , Asmita Wele  3 , Pravin Soni  4 , Pranesh Gaikwad  5 , Anirban Pal  6 , Dnyaneshwar U Bawankule  1   6 , Debabrata Chanda  6
Affiliations

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

Karuna Shanker et al. Phytomed Plus. 2023 Feb.

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.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper

Figures

Image, graphical abstract
Graphical abstract
Fig 1
Fig. 1
Representative HPLC chromatogram of – A) Andrographis paniculata aerial part, B) standardized extract, and C) CIM-MEG19 showing the presence of key labdane diterpenes. HPLC method parameters are summarized in the Chromatogram-B.
Fig 2
Fig. 2
CONSORT flow diagram of the current study.
See this image and copyright information in PMC

References

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