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An Investigator-initiated and Conducted Multicentre, Prospective, Randomised, Double-blinded Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Chinese Herbal Medicine in Patients With Acute Intracerebral Haemorrhage
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study aims to determine the effectiveness and safety of TCM in a larger sample of patients with moderate-severe ICH and provide evidence for TCM clinical guidelines on ICH management. The presumed mechanism of action is in promoting the reabsorption of the haematoma and perihematomal oedema in ICH.
Details
| Lead sponsor | Guangzhou University of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 1504 |
| Start date | 2021-10 |
| Completion | 2025-01 |
Conditions
- Intracerebral Hemorrhage
Interventions
- Chinese herbal medicine FYTF-919
Primary outcomes
- Utility-weighted modified Rankin scale scores — 90 days after the treatment started
Utility-weighted modified Rankin scale scores. The value range from 0 to 10: higher scores mean a better outcome.
Countries
China