Frontiers in Pharmacology (Jan 2023)

Huashi baidu granule in the treatment of pediatric patients with mild coronavirus disease 2019: A single-center, open-label, parallel-group randomized controlled clinical trial

  • Jiande Chen,
  • Qiuyu Tang,
  • Baoqin Zhang,
  • Shuhua Yuan,
  • Jia Chen,
  • Shiyu Shen,
  • Dong Wang,
  • Jilei Lin,
  • Hongliang Dong,
  • Yong Yin,
  • Jian Gao

DOI
https://doi.org/10.3389/fphar.2023.1092748
Journal volume & issue
Vol. 14

Abstract

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Background: Since late February 2022, a wave of coronavirus disease 2019 (COVID-19) mainly caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly appeared in Shanghai, China. Traditional Chinese medicine treatment is recommended for pediatric patients; however, the safety and efficacy remain to be confirmed. We conducted a single-center, open-label, parallel-group randomized controlled trial to assess the efficacy and safety of a Chinese herb compound, Huashi Baidu granule (HSBDG) in pediatric patients with laboratory-confirmed mild COVID-19.Methods: 108 recruited children (aged 3–18 years) with laboratory-confirmed mild COVID-19 were randomly allocated 2:1 to receive oral HSBDG for five consecutive days (intervention group) and to receive compound pholcodine oral solution for five consecutive days (control group). The negative conversion time of SARS-CoV-2 nucleic acid and symptom scores were recorded.Results: The median negative conversion time of SARS-CoV-2 nucleic acid was significantly shorter in the intervention group than in the control group (median days [interquartile range (IQR)]: 3 [3–5] vs. 5 [3–6]; p = 0.047). The median total symptom score on day 3 was significantly lower in the intervention group than in the control group (median total symptom score [IQR]: 1 [0–2] vs. 2 [0–3]; p = 0.036). There was no significant differences in the frequency of antibiotic use and side effects between the two groups.Conclusion: HSBDG is a safe, effective oral Chinese herbal compound granule, which shows a good performance within the Omicron wave among pediatric patients.

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