Efficacy evaluation of Jinghua Jiedu Formula for patients with mild COVID-19
Objective:To evaluate the efficacy and safety of Jinghua Jiedu Formula(JHJD)for patients with mild COVID-19.Methods:A randomized,double-blind,placebo-controlled trial was conducted,and patients with mild COVID-19 treated in Fang-Cang Hospital of Zhengzhou Airport District from October 20 to December 5,2022 were randomly divided into experimental group and control group,with 125 patients in each group.The experimental group was given JHJD prescription mixture and the control group was given placebo,one dose a day for 14 days.The time of nucleic acid turning negative was used as the primary outcome,and the medication could be stopped if the isolation management standard was met.The time/rate of disappearance of clinical symptoms(fever,cough,chest tightness,shortness of breath,etc.),rate of conversion to moderate/severe type,mortality,adverse events,etc.,were used as secondary outcomes.Results:Twelve cases(5 cases in experimental group and 7 cases in control group)fell off,forming 238 cases(120 cases in experimental group and 118 cases in control group)conforming to the protocol set.There were no significant differences between the two groups in age,height,weight,hospitalization interval,co-morbidity and vaccination.The nucleic acid conversion time of experimental group was shorter than that of control group(P＜0.01),and the rate of nucleic acid negative conversion in the experimental group was significantly higher than that of the control group at 7-,10-and 14-days during treatment(P＜0.05,P＜0.01).The disappearance time of fever,cough and shortness of breath in experimental group was shorter than that in control group(P＜0.01,P＜0.05).The disappearance rate of fever in the experimental group at 4-days and the disappearance rate of cough at 7-days during treatment were higher than those in the control group(P＜0.05,P＜0.01).No cases conversion to moderate/severe or death in the two groups.Conclusion:JHJD can effectively shorten the negative conversion time of nucleic acid,improve the negative conversion rate of nucleic acid,and promote the disappearance of fever and cough symptoms in the treatment of patients with mild novel coronavirus infection,with good safety.
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