Jinhua Qinggan granules for non-hospitalized COVID-19 patients: A double-blind, placebo-controlled, and randomized controlled trial

Abstract

BackgroundKey findings from the World Health Organization Expert Meeting on Evaluation of Traditional Chinese Medicine (TCM) in treating coronavirus disease 2019 (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, non-hospitalized, laboratory-confirmed COVID-19 patients. Participants were randomly assigned to receive 5 g/sacket of JHQG or placebo granules orally thrice daily for 10 days. The primary outcomes were the improvement in clinical symptoms and a proportion tested negative on viral polymerase chain reaction (PCR) after treatment. Secondary outcomes were the time to recover from clinical symptoms and changes in white blood cells (WBC) and acute phase reactants (C-reactive protein (CRP) and ferritin) on the 10th day after treatment initiation.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%) on the 10th day of the trial 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 was comparable (rate difference: −4.67%; 95% CI −15.76 to 6.42). In contrast, 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 was shorter in the JHQG group compared to the placebo group (P < 0.001 for all). Three patients experienced mild-to-moderate adverse events (AEs) duringthe 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.ConclusionBased on the time to recover from the COVID-19-related symptoms and AEs, it is concluded that JHQG is a safe and effective TCM for symptomatic relief of patients with mild COVID-19. A symptomatic improvement in the JHQG group patients was observed and JHQG use would have important public health implications in such patients.Clinical Trial RegistrationThe Trial was prospectively registered on www.clinicaltrials.gov with registration number: NCT04723524.

Efficacy and safety of Jinhua Qinggan granules in the treatment of coronavirus disease 2019 (COVID-19): A systematic review and meta-analysis

“…The results from the included studies [ 15 – 17 , 24 ] yielded a combined sample size of 582 patients. Of the 4 studies, one was conducted in Pakistan and the remainder in China.…”

“…Three studies [ 15 , 17 , 24 ] were included to report the effect of Jinhua Qinggan granules on the rate at which COVID-19 patients resumed testing negative for SARS-COV-2 nucleic acids. The meta-analysis results of the random effects model showed that there was no statistically significant difference between the 2 groups [RR = 1.31, 95% CI (0.63, 2.71), P = .47] (Fig.…”

“…Two studies [ 17 , 24 ] reported the CT improvement rate of patients. Meta-analysis, using the fixed effect model [ P = .33, I 2 = 0%], showed that there was no statistically significant difference between the 2 groups [RR = 1.30, 95% CI (0.83, 2.04), P = .26] (Fig.…”

Effect of Lianhua Qingwen capsules on the positive rate of COVID-19 close contacts: A retrospective analysis of a large-scale population-based cohort study

“…Chinese studies have shown that TCM treatment combined with western medicines has an encouraging therapeutic effect on COVID-19 patients ( Huang et al, 2021 ; Ni et al, 2020 ; Shah et al, 2022 ; Zhu et al, 2022 ). The main principle of TCM theory in treating infectious diseases is strengthening the body's resistance to eliminate pathogenic factors.…”

Recent advances in Chinese patent medicines entering the international market

“…Shah et al conducted a phase 2/3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with Jinhua Qinggan granules in non-hospitalized patients with laboratoryconfirmed mild COVID-19 (28). They found that Jinhua Qinggan granules displayed better clinical efficacy (82.67%) compared to a placebo (10.74%), and the recovery time from symptoms such as a cough, phlegm, a sore throat, and headaches in patients receiving Jinhua Qinggan granules was shorter than that in patients receiving a placebo (6 days vs. more than 11 days).…”