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| Name | Class |
|---|---|
| Kaifeng Third People's Hospital | UNKNOWN |
| Second Affiliated Hospital of Tsinghua University | OTHER |
| Weifang Hospital of Traditional Chinese Medicine | OTHER |
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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.
The mortality and disability rate for intracerebral hemorrhage (ICH) is high, which places a severe burden on both families and society. Robot-assisted neurosurgery is a significant advancement in the development of minimally invasive surgery for ICH. Compared to conventional surgery, the advantages of robotic surgery include precise positioning, a shorter operative time, and greater stability. Cognitive impairment is a common comorbidity in patients with ICH, which significantly affects their daily life. The effectiveness of Fufang Congrong Yizhi Capsules (FCYC) in treating vascular dementia (VaD) and vascular cognitive impairment (VCI) is well established and has been documented in guidelines and expert consensus. So the primary objective of this clinical study is to observe the safety and efficacy of Fufang Congrong Yizhi Capsules (FCYC) of cognitive impairment after robot-assisted neurosurgery treatment for intracerebral hemorrhage
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment group | Active Comparator | Conventional treatment: blood pressure control and care as according to the current guidelines |
|
| FCYC group | Experimental | Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCYC+Conventional treatment | Drug | Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA) | It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome. | at baseline, 3 months, 6 months, 12 months |
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Inclusion criteria:
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qihui Zhang, MD. PhD | Contact | +86-10-67689749 | qihuizhang@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Qihui Zhang, MD. PhD | Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Tsinghua University | Recruiting | Beijing | Beijing Municipality | 100040 | China |
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| Shandong Public Health Clinical Center |
| OTHER_GOV |
| Kunming Sanbo Brain Hospital | UNKNOWN |
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| conventional treatment | Drug | The control group will receive the current gold standard treatment for ICH according to the guidelines (AHA/ASA 2022). This involves blood pressure and care. |
|
| Qinhuangdao Hospital of Traditional Chinese Medicine | Recruiting | Qinhuangdao | Hebei | 066000 | China |
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| Kaifeng Third People's Hospital | Recruiting | Kaifeng | Henan | 475000 | China |
|
| Shandong Public Health Clinical Center | Recruiting | Jinan | Shandong | 250102 | China |
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| Weifang Hospital of Traditional Chinese Medicine | Recruiting | Weifang | Shandong | 261041 | China |
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| Kunming Sanbo Brain Hospital | Recruiting | Kunming | Yunnan | 650100 | China |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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