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

Shanker et al., Phytomedicine Plus, doi:10.1016/j.phyplu.2022.100398, CTRI/2021/05/033543
Feb 2023  
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Progression 91% Improvement Relative Risk Time for 2-point improv.. 33% Viral clearance 6% Andrographolide  Shanker et al.  EARLY TREATMENT Is early treatment with andrographolide beneficial for COVID-19? Prospective study of 80 patients in India Faster recovery with andrographolide (p<0.000001) c19early.org Shanker et al., Phytomedicine Plus, Feb 2023 Favorsandrographolide Favorscontrol 0 0.5 1 1.5 2+
80 mild/moderate hospitalized COVID-19 patients in India, 40 treated with CIM-MEG19 (standardized Andrographis paniculata formulation), showing faster recovery, lower progression, and favorable changes in inflammatory markers, however the study is difficult to interpret because patients treated with remdesivir/favipiravir were only considered for the control arm, resulting in higher baseline severity in the control arm, and a comparison between andrographis and remdesivir/favipiravir.
This study is excluded in meta analysis: biased randomization with significant baseline differences that were not adjusted for.
risk of progression, 90.9% lower, RR 0.09, p = 0.05, treatment 0 of 40 (0.0%), control 5 of 40 (12.5%), NNT 8.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
time for 2-point improvement on WHO scale, 33.1% lower, RR 0.67, p < 0.001, treatment mean 4.17 (±0.56) n=30, control mean 6.23 (±1.95) n=32.
risk of no viral clearance, 5.9% lower, RR 0.94, p = 1.00, treatment 15 of 30 (50.0%), control 17 of 32 (53.1%), NNT 32.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Shanker et al., 28 Feb 2023, prospective, India, peer-reviewed, 8 authors, trial CTRI/2021/05/033543. Contact: k.shanker@cimap.res.in, kspklko@yahoo.com, dr.rangnekar@gmail.com, asmita.wele@bharatividyapeeth.edu, drpravinsoni18@gmail.com, pranesh.gaikwad@dpu.edu.in, a.pal@cimap.res.in, du.bawankule@cimap.res.in, d.chanda@cimap.res.in.
This PaperAndrographol..All
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
Phytomedicine Plus, doi:10.1016/j.phyplu.2022.100398
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.
Declaration of Competing Interest 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 Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.phyplu.2022.100398.
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