FCYC+Conventional treatment
DrugConventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment.
NCT Number: NCT06673602
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Second Affiliated Hospital of Tsinghua University, Beijing, Beijing Municipality, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment.
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.
Time frame: at baseline, 3 months, 6 months, 12 months
It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome.
Contact information is provided by the study sponsor or research team.
Qinhuangdao Hospital of Traditional Chinese Medicine
Other
Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)
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