Reyanning Mixture on Asymptomatic or Mild SARS-CoV-2 Infection in Children and Adolescents: A Randomized Controlled Trial

Xiang-Ru Xu; Shuang Zhou; Guo-Qiang Jin; Hong-Ze Wu; Jin-Hua Li; Jing Zhou; Wei Peng; Wen Zhang; Ding Sun; Bang-Jiang Fang

doi:10.1007/s11655-023-3609-0

Reyanning Mixture on Asymptomatic or Mild SARS-CoV-2 Infection in Children and Adolescents: A Randomized Controlled Trial

Chin J Integr Med. 2023 Oct;29(10):867-874. doi: 10.1007/s11655-023-3609-0. Epub 2023 Jul 31.

Authors

Xiang-Ru Xu¹, Shuang Zhou², Guo-Qiang Jin³, Hong-Ze Wu⁴, Jin-Hua Li⁴, Jing Zhou⁵, Wei Peng¹, Wen Zhang¹, Ding Sun¹, Bang-Jiang Fang^{6

7}

Affiliations

¹ Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
² Acupuncture and Massage College, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
³ Department of Health Management, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
⁴ Jiangxi Provincial Traditional Chinese Medicine Nephropathy Clinical Research Center, Jiujiang Hospital of Traditional Chinese Medicine, Jiujiang, Jiangxi Province, 332099, China.
⁵ Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
⁶ Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. fangbji@163.com.
⁷ Institute of Critical Care, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. fangbji@163.com.

PMID: 37523100
DOI: 10.1007/s11655-023-3609-0

Abstract

Objective: To assess the effect and safety of Reyanning Mixture (RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents.

Methods: This is a prospective, open-label, randomized controlled trial. Patients aged 1-17 years and diagnosed with asymptomatic or mild coronavirus disease-2019 (COVID-19) were assigned to an intervention group (RYN plus standard care) and a control group (standard care) according to a randomization list. The primary outcomes were SARS-CoV-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold (Ct) values of ORF1ab or N genes were also tested.

Results: A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days (interquartile range (IQR): 5-6) vs. 7 days (IQR: 6-7), P<0.01]. By days 3 and 7, the negative conversion rates were significantly higher in the intervention group (day 3: 32.7% vs. 21.2%, P=0.007; day 7: 75.2% vs. 60.8%, P=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62 (IQR: 29.17-45.00) vs. 34.22 (IQR: 28.41-39.41), P=0.03; N gene: 34.97 (IQR: 28.50-45.00) vs. 33.51 (IQR: 27.70-38.25), P=0.024] and day 3 [ORF1ab gene: 38.00 (IQR: 32.72-45.00) vs. 35.81 (IQR: 29.96-45.00), P=0.003; N gene: 37.16 (IQR: 32.01-45.00) vs. 35.26 (IQR: 29.09-45.00), P=0.01]. No significant difference was found in hospital length of stay between the two groups (P>0.05). Symptoms of cough were significantly improved (82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced (0.7% vs. 12.9%, P<0.01) in the intervention group compared with the control group. During the trial, no disease progression or serious adverse events were reported.

Conclusion: Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-CoV-2 infection. (Registration No. ChiCTR2200060292).

Keywords: Chinese medicine; Omicron; Reyanning Mixture; children; coronavirus diseases-2019; randomized controlled trial; severe acute respiratory syndrome coronavirus 2.