Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage

Qinhuangdao Hospital of Traditional Chinese Medicine

Status and phase: Enrolling; Phase 4

Conditions: Cognitive Impairment; Intracerebral Hemorrhage

Treatments: Drug: conventional treatment; Drug: FCYC+Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06673602

ZW2023A005

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Conventional treatment group

Active Comparator group

Description:

Conventional treatment: blood pressure control and care as according to the current guidelines

Treatment:

Drug: conventional treatment

FCYC group

Experimental group

Description:

Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment

Treatment:

Drug: FCYC+Conventional treatment