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Journal of Traditional Chinese Medicine >

2022 , Vol. 42 >Issue 5: 803 - 809

DOI: https://doi.org/10.19852/j.cnki.jtcm.20220719.003

Research Articles

Shugan Jieyu capsule (舒肝解郁胶囊) improve sleep and emotional disorder in coronavirus disease 2019 convalescence patients: a randomized, double-blind, placebo-controlled trial

  • Xuedong AN ,
  • Qing ZHANG ,
  • Junxiu TAO ,
  • Li LI ,
  • Yun CHEN ,
  • Kejian LI ,
  • Jing HE ,
  • Ru LIU ,
  • Juan GUO ,
  • Jia ZHANG ,
  • Hui ZHU ,
  • Fengmei LIAN ,
  • Xiaodong LI
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  • 1 Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100053, China
    2 Orthopedics, Hubei Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Hubei University of Chinese Medicine, Hubei Institute of Traditional Chinese Medicine, Wuhan 430000, China
    3 Liver Disease branch, Hubei Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Hubei University of Chinese Medicine, Hubei Institute of Traditional Chinese Medicine, Wuhan 430000, China
    4 Psychology Department, Hubei Provincial Hospital of TCM, Affiliated Hospital of Hubei University of Chinese Medicine, Hubei Institute of Traditional Chinese Medicine, Wuhan 430000, China
    5 Clinical College of Traditional Chinese Medicine, Hubei University of Traditional Chinese Medicine, Wuhan 430061, China
LI Xiaodong, Liver Disease branch, Hubei Hospital of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Affiliated Hospital of Hubei University of Chinese Medicine, Hubei Institute of Traditional Chinese Medicine, Wuhan 430000, Lixiaodong555@126.com Telephone: +86-13651249262; +86-13908658127
LIAN Fengmei, Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing 100054, China, lfm565@sohu.com;

Received date: 2022-03-12

  Accepted date: 2022-06-17

  Online published: 2022-07-19

Supported by

Mechanism and Countermeasure of COVID-19 asymptomatic infection and re-detectable positive in SARS-CoV-2 nucleic acid test(2020YFC0861100)

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Abstract

OBJECTIVE: To evaluate the efficacy of the Shugan Jieyu capsule (舒肝解郁胶囊) on improving sleep and emotional disorder during Coronavirus disease 2019 (COVID-19) convalescence.

METHODS: We conducted a randomized, double-blind, placebo-controlled trial, and recruit 200 COVID-19 convalescence patients and then divide the subjects into two groups respectively: the experimental group (n = 100) and the control group (n = 100). Patients in the control group were given doses as a placebo, while those in the experimental group were given Shugan Jieyu capsule. The investigators mainly observed the differences between the two groups before and after treatment in terms of the rate of reduction and the rate of efficiency in Hamilton Depression Scale (HAMD-17) total scores from baseline, and recorded the scores of Hamilton Anxiety Scale (HAMA), Patient Health Questionnaire-15 (PHQ-15), Insomnia Severity Index (ISI) and Treatment Emergent Symptom Scale at 2 week, the 4 week and the 6 week respectively after treatment, and compared the differences between the groups. And the occurrence of adverse events was recorded.

RESULTS: After 6-week treatment, there were statistically significant differences in the rate of reduction as well as efficiency in HAMD-17 scores, HAMA Total Scores, PHQ-15 Score, ISI Score from baseline in the experimental group and control group (P < 0.05). There were 4 adverse events in the experimental group and 1 in the control group.

CONCLUSION: Shugan Jieyu capsule could significantly improve sleep and emotional disorder in patients during COVID-19 convalescence.

Key words： COVID-19; convalescence; sleep quality; emotional disorder; Shugan Jieyu capsule

Cite this article

Xuedong AN , Qing ZHANG , Junxiu TAO , Li LI , Yun CHEN , Kejian LI , Jing HE , Ru LIU , Juan GUO , Jia ZHANG , Hui ZHU , Fengmei LIAN , Xiaodong LI . Shugan Jieyu capsule (舒肝解郁胶囊) improve sleep and emotional disorder in coronavirus disease 2019 convalescence patients: a randomized, double-blind, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2022 , 42(5) : 803 -809 . DOI: 10.19852/j.cnki.jtcm.20220719.003

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