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Efficacy and Safety of Andrographis Paniculata Extract in Patients with Mild COVID-19: A Randomized Controlled Trial

Wanaratna et al., Archives of Internal Medicine Research, doi:10.26502/aimr.0125 (date from preprint), TCTR20210708001
Jul 2021  
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Progression 86% Improvement Relative Risk Viral clearance 40% Andrographolide  Wanaratna et al.  EARLY TREATMENT  DB RCT Is early treatment with andrographolide beneficial for COVID-19? Double-blind RCT 57 patients in Thailand (December 2020 - March 2021) Lower progression (p=0.11) and improved viral clearance (p=0.11), not sig. c19early.org Wanaratna et al., Archives of Internal.., Jul 2021 Favorsandrographolide Favorscontrol 0 0.5 1 1.5 2+
RCT 63 mild COVID-19 patients showing lower progression and improved viral clearance with andrographis, without statistical significance.
risk of progression, 85.9% lower, RR 0.14, p = 0.11, treatment 0 of 29 (0.0%), control 3 of 28 (10.7%), NNT 9.3, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of no viral clearance, 39.7% lower, RR 0.60, p = 0.11, treatment 10 of 29 (34.5%), control 16 of 28 (57.1%), NNT 4.4, day 5.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Wanaratna et al., 11 Jul 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Thailand, peer-reviewed, 7 authors, study period December 2020 - March 2021, trial TCTR20210708001.
This PaperAndrographol..All
Efficacy and Safety of Andrographis Paniculata Extract in Patients with Mild COVID-19: A Randomized Controlled Trial
Kulthanit Wanaratna, Pornvimol Leethong, Nitapha Inchai, Wararath Chueawiang, Pantitra Sriraksa, Anutida Tabmee, Sayomporn Sirinavin
Archives of Internal Medicine Research, doi:10.26502/aimr.0125
Objectives: To assess the efficacy and safety of Andrographis paniculata extract (APE) in adults with mild COVID-19. Methods: Sixty-three adults aged 18-60 years, without co-morbidity, with laboratory-confirmed mild COVID-19, were randomized 1:1 to receive APE (60 mg andrographolide, t.i.d, for 5 days) or placebo within 24 hours after admission, plus standard supportive care. The outcomes were clinical recovery rates by Day 5 using self-assessment scores, pneumonia by chest X-rays, nasopharyngeal SARS-CoV-2 detection by rRT-PCR on Day 5, changes of serum CRP levels, and adverse drug reactions. Chest X-rays and blood tests for CRP, liver and renal function, were performed on Days 1, 3, and 5. Results: Baseline characteristics of patients in the APE-treatment (n=29) and placebo-control (n=28) groups were comparable. None had self-assessment scores showing complete clinical recovery by Day 5. Pneumonia occurred in 0/29 (0%) versus 3/28 (10.7%), (p=0.112). On Day 5, patients with SARS-CoV-2 detection were 10/29 (34.5%) versus 16/28 (57.1%), (p=0.086); patients with CRP >10 mg/L were 0/29 (0%) versus 5/28 (17.9%), (p=0.023), for APE-treatment and placebo-control groups, respectively. All three patients with pneumonia had substantially rising serum CRP; and high CRP levels on Day 5. None had evidence of hematologic, hepatic or renal impairment. Conclusion: Even though the study was limited by small sample size, our findings suggested promising efficacy and safety of the APE-treatment regimen in adults with mild COVID-19. Further studies, with adequate power to assure these findings, are required.
Potential Conflicts of Interest The authors have no conflicts of interest to declare. Ethics Approval and Consent to Participate Ethical approval was obtained from the Ethics Committee for Research in Human Subjects in the Fields of Thai Traditional and Alternative Medicine (No.12-2563). All participants gave written informed consent.
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