Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study

2005 ◽  
Vol 3 (3) ◽  
pp. 191-194 ◽  
Author(s):  
Jin-Gen Lu
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Clinical Study ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine

scholarly journals The Reporting Quality Assessment of Complex Interventions’ Articles in Traditional Chinese Medicine

2013 ◽  
Vol 2013 ◽  
pp. 1-8
Author(s):  
Meng Wu ◽  
Jingqing Hu ◽  
Biaoyan Liu
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Complex Interventions ◽  
Reporting Quality ◽  
Chinese Journal ◽  
Inform Consent ◽  
Ethical Approval ◽  
Selection Of

Objective.To realize the current situation and problems of complex interventions’ clinical trials.Methods.Searching at Chinese Journal Integrated Traditional and Western Medicine and Journal of Traditional Chinese Medicine from 2007 to 2012 by hand, we identified complex interventions’ articles, and then we used the proposed criteria of complex interventions and CONSORT FOR TCM to evaluate.Results.All data is presented as counts with percentages and details in tables.Conclusion.Our evaluation presented that complex interventions have many defects: the selection of the intervention’s components lacks rationale, complex interventions were short of fundamental researches, components’ interactions were ambiguous, and the advantages of complex interventions were not mentioned. Furthermore, explanation of sample size, blind, quality control, ethical approval, and inform consent were neglected in different degrees.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

Sign in / Sign up

Export Citation Format

Share Document