Ludangshen oral liquid for treatment of convalescent COVID-19 patients: a randomized, double-blind, placebo-controlled multicenter trial

Abstract

Objective To explore the effect of Ludangshen oral liquid for treatment of convalescent patients with coronavirus disease 2019 (COVID-19) with randomized, double-blind, placebo-controlled multicenter method. Methods 200 convalescent COVID-19 patients who had symptoms related to decreased digestive and respiratory function were randomly divided to either receive Ludangshen oral liquid or placebo for 2 weeks. The severity of clinical symptoms including fatigue, anorexia, abdominal distension, loose stools, and shortness of breath were assessed by visual analogue scale and observed at before and after treatment. The improvement and resolution rates of clinical symptoms were evaluated. Full analysis set (FAS) and per-protocol set (PPS) were used for statistical analyses. Adverse events were recorded during the study. Results 8 patients did not complete the study. After 2 weeks of treatment, both FAS and PPS results showed that patients in Ludangshen group had significantly lower score of fatigue, anorexia, loose stools, and shortness of breath than placebo group (P < 0.05), while there was no significant difference in distention (P > 0.05). The improvement rate of fatigue, anorexia, distension, loose stools and shortness of breath were significantly higher in Ludangshen group (P < 0.05), as well as the resolution rates (P < 0.05) except for shortness of breath (P > 0.05). There were two cases of adverse events, with one nose bleeding in Ludangshen group and one headache in placebo group. Conclusion The study suggested that two weeks of Ludangshen oral liquid treatment may have certain effects for convalescent COVID-19 patients on improving digestive and respiratory symptoms including fatigue, anorexia, loose stools and shortness of breath, which may be one of the choices for management of convalescent COVID-19 patients with digestive and respiratory symptoms.

Traditional, complementary and integrative medicine for fatigue post COVID-19 infection: A systematic review of randomized controlled trials

“…Thirteen RCTs 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 with 1632 participants of searched 37,281 records were included ( Fig 1 ). Details of the 87 articles excluded at full-text screen with reasons are reported in Supplement 2.…”

“…Further details are reported in Supplement 4. Participants from eight RCTs conducted in China 25 , 26 , 27 , 28 , 33 , 34 , 36 , 37 and were diagnosed as convalescent COVID-19 according to “The Diagnosis and Treatment Scheme of COVID-19” released by the National Health Commission of the People's Republic of China. 38 , 39 Four of these studies also specified a traditional Chinese medicine syndrome diagnosis for the inclusion criteria.…”

“…38 , 39 Four of these studies also specified a traditional Chinese medicine syndrome diagnosis for the inclusion criteria. 26 , 28 , 36 , 37 The average or median time since discharge from medical isolation ranged from 2 to 11 weeks. Further details about participant characteristics are reported in Table 1 and Supplement 5.…”

Advances in the application of traditional Chinese medicine during the COVID-19 recovery period: A review

“…14/14 Symptom VAS Improve certain symptoms related to decreased digestive and respiratory functions An X et al [52] 2022…”

Analysis of Prognostic Factors and Establishment of a Nomogram to Predict Risk for COVID-19 Convalescent Patients Based on Metabolomic and Lipidomic

“…Numerous pharmacological and non-pharmacological therapies in Traditional Chinese Medicine (TCM) have demonstrated effectiveness in alleviating clinical symptoms such as fatigue, anorexia, loose stools, shortness of breath, insomnia, anxiety, and depression. Moreover, these therapies have been shown to enhance lung function and reduce the re-positivity rate of SARS-CoV-2 nucleic acid (An et al, 2022;Chen et al, 2022;He et al, 2020;Li et al, 2021). One speci c TCM compound, the Qimai Feiluoping Mixture (QM), was formulated by Academician Tong Xiaolin for individuals with abnormal lung CT during the convalescence period of COVID-19 in Wuhan.…”