Jinhua Qinggan Granules for Nonhospitalized COVID-19 Patients: a Double-Blind, Placebo-Controlled, Randomized Controlled Trial

Abstract

BackgroundKey findings from the World Health Organization Expert Meeting on Evaluation of Traditional Chinese Medicine in treating COVID-19 reported that TCMs are beneficial, particularly for mild-to-moderate cases. The efficacy of Jinhua Qinggan Granules (JHQG) in COVID-19 patients with mild symptoms has yet to be clearly defined.MethodsWe conducted a phase 2/3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with JHQG in mild, nonhospitalized, laboratory-confirmed COVID-19 patients. Participants were randomly assigned to receive 5g/sacket of JHQG or placebo granules orally thrice daily for 10 days. The primary outcomes were the improvement in clinical symptoms and proportion tested negative on viral PCR after treatment. Secondary outcomes were the time to recovery from clinical symptoms and changes in white blood cells (WBC) and acute phase reactants (C-reactive protein (CRP) and ferritin) 10-15 days after treatment.ResultsA total of 300 patients were randomly assigned to receive JHQG (150 patients) and placebo (150 patients). Baseline characteristics were similar in the two groups. In the modified intention-to-treat analysis, JHQG showed greater clinical efficacy (82.67%) after 10 days of treatment compared with the placebo group (10.74%) (rate difference: 71.93%; 95% CI 64.09 - 79.76). The proportion of patients with a negative PCR after treatment were comparable (rate difference: -4.67%; 95% CI -15.76 - 6.42). While all changes in WBC, ferritin, and CRP levels showed a statistically significant decline in JHQG (P≤0.044) after treatment, but not the latter in placebo (P=0.077). The median time to recovery of COVID-19 related symptoms including cough, sputum, sore throat, dyspnea, headache, nasal obstruction, fatigue, and myalgia were shorter in the JHQG group compared to the placebo group (P<0.001 for all). 3 patients experienced mild to moderate adverse events during the treatment period in the JHQG group. Findings were similar between the modified intention-to-treat and the per-protocol analysis that included only patients who reported 100% adherence to the assigned regimen.ConclusionsJHQG is a safe and effective TCM for the treatment of mild COVID-19 patients.Clinical Trial RegistrationThe Trial was prospectively registered on www.clinicaltrials.gov with registration number: NCT04723524.

Effect of Traditional Chinese Medicine in patients with COVID-19: A multi-center retrospective cohort study

“…Secondly, the SARS-CoV-2 strain of the patients included in this study is partially different from the currently prevalent SARS-CoV-2 Omicron variant in clinical features (such as infectivity and immune escape) [31]. However, considering the wide applicability of TCM and the exact curative effect on various variant strains, the results of this study can still provide evidence to support the current treatment of COVID-19 and new respiratory infectious diseases in the future [32].…”

Initial observations of Jinhua Qinggan Granules, a Chinese medicine, in the mitigation of hospitalization and mortality in high-risk elderly with COVID-19 infection: A retrospective study in an old age home in Hong Kong

“…We recently completed a double-blind, placebo-controlled, randomized controlled trial conducted in non-hospitalized Pakistani patients with mild COVID-19 infection ( 12 ). The findings, under review, demonstrated that early administration of JHQG led to effective relief of viral infection symptoms.…”

“…In the past, JHQG has been utilized in the treatment of the H1N1 influenza, and has been shown to effectively alleviate symptoms and promote recovery among influenza patients ( 10 , 11 ). Our group was involved in a recent study that demonstrated that JHQG was effective in promoting recovery from COVID-19 related symptoms and suppressing acute phase reactants in a group of Pakistani patients with mild COVID-19 infections ( 12 ). Nonetheless, there is currently no evidence in the literature to evaluate the efficacy of JHQG in the reduction of hospitalization and mortality of COVID-19 patients who are at high risk of progression.…”