Reyanning Mixture on Asymptomatic or Mild SARS-CoV-2 Infection in Children and Adolescents: A Randomized Controlled Trial.
10.1007/s11655-023-3609-0
- Author:
Xiang-Ru XU
1
;
Shuang ZHOU
2
;
Guo-Qiang JIN
3
;
Hong-Ze WU
4
;
Jin-Hua LI
4
;
Jing ZHOU
5
;
Wei PENG
1
;
Wen ZHANG
1
;
Ding SUN
1
;
Bang-Jiang FANG
6
,
7
Author Information
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@
7. com.
- Publication Type:Journal Article
- Keywords:
Chinese medicine;
Omicron;
Reyanning Mixture;
children;
coronavirus diseases-2019;
randomized controlled trial;
severe acute respiratory syndrome coronavirus 2
- From:
Chinese journal of integrative medicine
2023;29(10):867-874
- CountryChina
- Language:English
-
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).
