LI Hongjiao, LIU Baoyan, WEN Zehuai, et al. Design Ideas and Methods for Post-market Re-evaluation of Anti-virus Oral Liquid in Treatment of Adult Cold[J]. Journal of Traditional Chinese Medicine2018, 59(5): 386-389.
LI Hongjiao, LIU Baoyan, WEN Zehuai, et al. Design Ideas and Methods for Post-market Re-evaluation of Anti-virus Oral Liquid in Treatment of Adult Cold[J]. Journal of Traditional Chinese Medicine2018, 59(5): 386-389.DOI: 10.13288/j.11-2166/r.2018.05.007.
During the design of the post-market re-evaluation study of antiviral oral liquid in the treatment of adult cold
the hypothesis was put forward based on the comprehensive analysis of the sponsor’s research orientation
research background and research basis
which was that the anti-viral oral solution had a significant effect on adult cold after expanding dose. The randomized controlled trial was determined to verify the hypothesis. The key elements such as subjects
interventions
controls and outcome indicators were designed with reference to the characteristics of the Chinese herb combinations in the formula to infer the indications
the instruction
the early website survey
results of clinician interviews and foreign clinical trials of common cold drugs. At the same time
this study designed the contents and methods to control the quality against the potential risks that might affect the quality of study.