Clinical trial NCT06673602: Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
Official title: Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cognitive Impairment
Intracerebral Hemorrhage
Keywords: Cognitive Impairment
Intracerebral Hemorrhage
robot-assisted neurosurgery treatment
Fufang Congrong Yizhi Capsules
Lead sponsor: Qinhuangdao Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Kaifeng Third People's Hospital
name: Second Affiliated Hospital of Tsinghua University
name: Weifang Hospital of Traditional Chinese Medicine
name: Shandong Public Health Clinical Center
name: Kunming Sanbo Brain Hospital
First posted: 2024-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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, syphilis, and acquired immune deficiency syndrome(AIDS);
3. Patients are unable to participate in the examination who have severe visual or auditory impairments, apraxia, aphasia, or apparent neurological abnormalities;
4. Patients with communication difficulties, patients with mental illness;
5. Patients with depression, Hamilton Depression Scale ( HAMD ) ≥ 17 points;
6. Patients with alcohol or drug dependency diagnosed within 6 months;
7. Patients with severe liver, kidney, or heart failure or other serious primary diseases;
8. Preconceptional, lactating, and pregnant women

Primary outcomes:
measure: Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA)
timeFrame: at baseline, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Second Affiliated Hospital of Tsinghua University
state: Beijing
city: Qinhuangdao
country: China
facility: Qinhuangdao Hospital of Traditional Chinese Medicine
state: Hebei
city: Kaifeng
country: China
facility: Kaifeng Third People's Hospital
state: Henan
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
city: Weifang
country: China
facility: Weifang Hospital of Traditional Chinese Medicine
state: Shandong
city: Kunming
country: China
facility: Kunming Sanbo Brain Hospital
state: Yunnan
Study officials:
affiliation: Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine
name: Qihui Zhang, MD. PhD
role: STUDY_DIRECTOR
References: