Jinhua Qinggan Granules for Nonhospitalized COVID-19 Patients: a Double-Blind, Placebo-Controlled, Randomized Controlled Trial
Muhammad Raza Shah, Samreen Fatima, Sehrosh Naz Khan, Shafiullah, Gulshan Himani, Kelvin Wan, Timothy Lin, Johnson Y N Lau, Qingquan Liu, Dennis S C Lam
doi:10.1101/2022.05.16.22275074
Background: Key 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.
Methods: We conducted a phase 2/3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with JHQG in mild, nonhospitalized, laboratoryconfirmed 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. Results: A 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% . 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. Conclusions: JHQG is a safe and effective TCM for the treatment of mild COVID-19 patients.
To our knowledge, this is the first RCT to evaluate the clinical efficacy and safety of JHQG in the treatment of laboratory-confirmed nonhospitalized COVID-19 patients. Various limitations of this trial should be noted. The basic reason for dropout was that the subjects were unable or unwilling to continue the clinical trial and voluntarily requested to withdraw The study included only COVID-19 patients of Pakistani race, and may limit the geographic generalizability of the findings. This study also excluded patients with severe underlying medical conditions, who are at particularly heightened risk of COVID-19 disease progression. Future studies of JHQG in COVID-19 shall focus on evaluating the clinical efficacy and safety of this TCM in such group of patients. In conclusion, our data show that JHQG is a safe and effective treatment for COVID-19 patients with mild symptoms.
Conflict of interests The authors declare that they have no conflict of interests.
Ethical Statement This study was conducted according to the ethical principles that have their origin in Declaration of Helsinki. The study protocol was reviewed and approved by the Institutional ethics committee
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'abstract': '<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Key '
'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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We 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 '
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'300 patients were randomly assigned to receive JHQG (150 patients) and placebo (150 '
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'intention-to-treat analysis, JHQG showed greater clinical efficacy (82.67%) after 10 days of '
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'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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>JHQG is a '
'safe and effective TCM for the treatment of mild COVID-19 '
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