RESUMO
OBJECTIVE: This randomized, double-blind, controlled trial (RCT) aimed to evaluate the effect of Phyllanthus Emblica (Amla) as an add-on therapy on COVID-19_ related biomarkers and clinical outcomes in COVID-19 patients. METHODS: In this RCT, sixty-one patients were randomly assigned into two arms [the intervention (n=31) and control arms (n=30)]. The effect of Amla on diagnostic Reverse-transcription Polymerase Chain Reaction (RT-PCR) test results between the first and the last days of the study, the length of stay (LOS) in hospital, the percentage of lung involvement on CT scans, changes in the clinical symptoms, and the laboratory markers were assessed. RESULTS: The two study groups had similar baseline demographics and characteristics in terms of medical history. The mean of LOS in the intervention arm (4.44 days) was significantly shorter than in the control arm (7.18 days, P < 0.001); RT-PCR results were not significantly different between the two arms (P = 0.07). All clinical variables decreased over time in the two groups (P < 0.001). However, the difference between the two groups in terms of fever (P = 0.004), severity of cough (P = 0.001), shortness of breath (P = 0.004), and myalgia (P = 0.005) were significant, but this intergroup comparison was not significant with regard to respiratory rate (P = 0.29), severity of chills (P = 0.06), sore throat (P = 0.22), and weakness (P = 0.12). Out of the eight evaluated para-clinical variables, three variables showed significant improvement in the intervention arm, including the mean increase in oxygen saturation (SpO2) level (P < 0.001), the reduction in the mean percentage of lung involvement on CT (P < 0.001), and the improvement in C-reactive protein test results (P < 0.001). CONCLUSION: Organic herbal Amla tea cannot significantly affect the RT-PCR results and or degree of lung involvement. Nevertheless, it showed an ameliorative effect on the severity of clinical signs and CRP levels. Also, Amla tea may shorten the recovery times of symptoms and LOS in COVID-19 patients.