Combination of Hua Shi Bai Du granule (Q-14) and standard care in the treatment of patients with coronavirus disease 2019 (COVID-19): A single-center, open-label, randomized controlled trial

  1. Jia Liu
  2. Wei Yang
  3. Yue Liu
  4. Cheng Lu
  5. Lianguo Ruan
  6. Chen Zhao
  7. Ruili Huo
  8. Xin Shen
  9. Qing Miao
  10. Wenliang Lv
  11. Hao Li
  12. Huaxin Shi
  13. Lijie Hu
  14. Zhixu Yang
  15. Li Zhang
  16. Bing Wang
  17. Guoju Dong
  18. Yongyue Xian
  19. Bin Li
  20. Zhenqi Zhou
  21. Chunyan Xu
  22. Yingying Chen
  23. Yongjun Bian
  24. Jing Guo
  25. Jinliang Yang
  26. Jian Wang
  27. Wensheng Qi
  28. Suping Chen
  29. Yang Chen
  30. Bei Yan
  31. Wei Wang
  32. Jing Li
  33. Xiaolei Xie
  34. Ming Xu
  35. Jianxin Jiang
  36. Gang Wang
  37. Xiaodong Cong
  38. Haoning Zhu
  39. Jiaheng Shi
  40. Luxing Leng
  41. Dongxu Li
  42. Lanping Guo
  43. Luqi Huang

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Abstract

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  1. Version published to 10.1016/j.phymed.2021.153671
  2. ScreenIT

    SciScore for 10.1101/2021.01.25.21249417: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study protocol had been approved by the Ethics Review Committee of China Academy of Chinese Medical Sciences.
    Consent: All patients had given written informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableThe exclusion criteria included: 1) Critical patients; 2) Patients who cannot guarantee compliance of using Q-14 during the treatment period, or patients who are difficult to take medicine by oral or nasal route; 3) Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID-19; 4) Pregnant or parturient women including patient who have a pregnancy plan or a positive urine pregnancy test; 5) Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, etc., which the researchers consider unsuitable for participation in the trial; 6) Patients who have been allergic or intolerant to taking Chinese medicine herb.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    In this study, statistical packages base, Stats, Rcompanion and survival in R version-3.6.2 and SPSS 20.0 were used for statistical analysis and verification.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.01.25.21249417v1 on medRxiv