Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
- Conditions
- Cognitive ImpairmentIntracerebral Hemorrhage
- Interventions
- Drug: conventional treatmentDrug: FCYC+Conventional treatment
- Registration Number
- NCT06673602
- Lead Sponsor
- Qinhuangdao Hospital of Traditional Chinese Medicine
- 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional treatment group conventional treatment Conventional treatment: blood pressure control and care as according to the current guidelines FCYC group FCYC+Conventional treatment Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment
- Primary Outcome Measures
Name Time Method Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA) at baseline, 3 months, 6 months, 12 months It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Second Affiliated Hospital of Tsinghua University
🇨🇳Beijing, Beijing, China
Qinhuangdao Hospital of Traditional Chinese Medicine
🇨🇳Qinhuangdao, Hebei, China
Kaifeng Third People's Hospital
🇨🇳Kaifeng, Henan, China
Shandong Public Health Clinical Center
🇨🇳Jinan, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
🇨🇳Weifang, Shandong, China
Kunming Sanbo Brain Hospital
🇨🇳Kunming, Yunnan, China
Second Affiliated Hospital of Tsinghua University🇨🇳Beijing, Beijing, ChinaYu MaContact