Guangdong Province Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
NCT Number: NCT05483595
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine Zhongfengxingnao formula (ZFXN) in reducing haematoma and bleeding after acute intracerebral hemorrhage (ICH) from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study is designed to evaluate the blinding and physical consistency between the investigational drug and placebo in RCT, taking the trial named Chinese herbal medicine in patients with acute intracerebral hemorrhage (CHAIN) as an example. Therefore the blinding of placebo as well as and physical consistency with investigated TCM in CHAIN trial will be determined. In addition, an assessment method for blinding and physical consistency could be developed for subsequent placebo evaluations.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510120, China
A total of 48 subjects will be divided into two parts for manual scoring, which includes not only the proportion of the discrimination to ZFXN, which is the primary outcome in this study, but also the physical (odor, taste) consistency of the two drugs. The primary outcome was the percentage of ZFXN response. The secondary outcomes included artificial sensory score and intelligent sensory attributes of testing drug.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral liquid 10ml
Other names: Zhong Feng Xing Nao (ZFXN) prescription
Time frame: Within 10 minutes after the first test.
The incidence of judging testing drug as ZFXN
Time frame: Within 10 minutes after the second test.
Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs. The value range from 0 to 10: higher scores mean a better consistency.
Time frame: Immediately after testing by electronic nose an electronic tongue.
Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs.
Guangzhou University of Traditional Chinese Medicine
Other
An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo: A Randomized Double-blind Clinical Trial
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