NCT06673602 Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
| NCT ID | NCT06673602 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qinhuangdao Hospital of Traditional Chinese Medicine |
| Condition | Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2026-06-30 |
Trial Parameters
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Brief Summary
This is a randomized, controlled clinical study conducted across multiple centers. The neurosurgical robot can be used to treat patients with acute intracerebral hemorrhage (ICH). Establish a cohort comprising 200 participants with cognitive impairment after robot-assisted neurosurgery treatment for ICH. Two hundred participants are randomly assigned to either an experimental group (n=100) or a control group (n=100). The experimental group receive conventional treatment and oral administration of Fufang Congrong Yizhi Capsules (FCYC) for 12 weeks, while the control group receive only conventional treatment. The object of the current study is 1) to observe the security and effectiveness of FCYC and 2) to decipher the contributing factors to cognitive impairment after robot-assisted neurosurgery treatment for intracerebral hemorrhage.
Eligibility Criteria
Inclusion criteria: 1. Meet the diagnostic criteria of intracerebral hemorrhage (ICH) and use a neurosurgical robot to treat ICH; 2. Meet diagnostic criteria for post-stroke cognitive impairment (PSCI); 3. Meet traditional Chinese medicine (TCM) diagnosis of deficiency of the liver and kidney, phlegm and stagnant blood obstructing the meridians pattern; 4. Aged 18 and above; 5. Not limit gender; 6. 2 weeks after the onset of ICH; 7. The participants are conscious, possess sufficient visual and auditory recognition, and are capable of undergoing neuropsychological evaluation; 8. Submit informed consent. Exclusion criteria : 1. Other types of dementia besides vascular dementia (VD), such as Alzheimer's disease(AD), dementia with Lewy bodies (DLB), and frontotemporal dementia; 2. Patients with other systemic diseases that can affect cognitive function, such as Parkinson's disease (PD), normal pressure hydrocephalus (iNPH), brain tumor, encephalitis, thyroid dysfunction, severe anemia, syp