Zhou, Yushu
Zhao, Baiming
Wu, Wanyin
Yang, Xiaobing
Long, Shunqin
Deng, Hong
He, Wenfeng
Liao, Guiya
Li, Qiuping
Xie, Zhen
Funding for this research was provided by:
the Administration of Traditional Chinese Medicine of Guangdong Province in China (20161085)
Article History
Received: 10 January 2018
Accepted: 6 August 2018
First Online: 4 September 2018
Ethics approval and consent to participate
: The trial protocol has been approved by the Research Ethical Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine (approval no. B2017–101-01). It will be monitored by the trial agency at Guangdong Provincial Hospital of Traditional Chinese Medicine. The study will be conducted in accordance with the principles of the Declaration of Helsinki (2013 version). The study design will comply with the principles set out in the Good Clinical Practice (GCP) guidelines according to the theory that guides the appropriate use of TCM in clinical application. The study design is in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [CitationRef removed] (see Additional file InternalRef removed). Informed consent will be obtained from all participants prior to entry into the trial including the possible risks, benefits, and knowledge of the purpose of the trial.The Ethics Committee of the GPHCM will review the study progress at least once a year. Any formal amendment to the protocol required must be approved by the Ethics Committee of the GPHCM prior to implementation if modifications may impact on the conduct of the study, potential benefit of the patient, or may affect patient safety. For the RCT, trained research nurses will introduce and discuss the trial information to interested patients, and a signed informed consent form will be obtained before each participant’s enrollment. Participants will be free to withdraw at any time.
: The authors declare that they have no competing interests.
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