OBJECTIVE: To evaluate the effectiveness and safety of Xiangsha Liujun pills (香砂六君丸) on the decreased digestive function in patients in the recovery phase of the Coronavirus disease 2019 (COVID-19).

METHODS: A randomized, double blind, placebo controlled clinical trial was conducted. A total of 200 COVID-19 patients in the recovery phase were included in our study in Ezhou Hospital of Traditional Chinese Medicine. Totally 200 subjects were randomly divided into a treatment group (Xiangsha Liujun pills) and a control group (placebo), with 100 in each group. Subjects took Xiangsha Liujun pills or placebo orally three times a day for two weeks. Three visits were scheduled at week 0 (baseline), week 1 (the middle of the intervention) and week 2 (the end of the intervention) for each eligible patient. The total efficacy rates for improving the Traditional Chinese Medicine (TCM) symptoms (fatigue, poor appetite, abdominal distension and loose stools) and the disappearance rates of symptoms were observed and compared in the treatment and control groups. Adverse events were recorded during the study period. SAS 9.4 was used to analyze the data.

RESULTS: A total of 200 patients were included in this study, among which 4 participants withdrew because the drugs did not work. Three patients were excluded for age. Before the treatment, there was no significant difference between the TCM symptoms scores of subjects. After 1 week of treatment, the full analysis set (FAS) showed that the efficacy rates for abdominal distension and loose stools in the treatment group were significantly higher than the control group (P < 0.05). There were no significant differences in the efficacy rates for fatigue and poor appetite between the two groups (P >0.05). In addition, the disappearance rate of fatigue in the treatment group was significantly higher than the control group (P <0.05); there were no significant differences between the two groups after treatment in the rates of poor appetite, abdominal distension, and loose stools (P>0.05). After 2 weeks of treatment, the efficacy rates for fatigue, poor appetite, abdominal distension, and loose stools in the treatment group were significantly higher than the control group (P <0.05). The disappearance rate of loose stools in the treatment group was significantly higher than the control group (P < 0.05). However, there were no significant differences in the disappearance rates of fatigue, poor appetite, and abdominal distension between the two groups (P > 0.05). No severe adverse events were reported by subjects during the study.

CONCLUSIONS: This clinical study confirmed that Xiangsha Liujun pills can effectively improve the symptoms related to the decreased digestive function in COVID-19 convalescent patients.