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An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo
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.
Details
| Lead sponsor | Guangzhou University of Traditional Chinese Medicine |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | Thu Sep 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Jun 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Placebo Evaluate
Interventions
- Chinese herbal medicine FYTF-919
Countries
China