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

Recruiting now · Phase 4

Conditions studied: Cognitive Impairment, Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT06673602

Run by

Qinhuangdao Hospital of Traditional Chinese Medicine

People needed

200

Starts

2024-11-04

Expected to finish

2026-06-30

Last updated by the study team

2024-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet the diagnostic criteria of intracerebral hemorrhage (ICH) and use a neurosurgical robot to treat ICH;
• Meet diagnostic criteria for post-stroke cognitive impairment (PSCI);
• Meet traditional Chinese medicine (TCM) diagnosis of deficiency of the liver and kidney, phlegm and stagnant blood obstructing the meridians pattern;
• Aged 18 and above;
• Not limit gender;
• 2 weeks after the onset of ICH;
• The participants are conscious, possess sufficient visual and auditory recognition, and are capable of undergoing neuropsychological evaluation;
• Submit informed consent.

You may not qualify if…

• Other types of dementia besides vascular dementia (VD), such as Alzheimer's disease(AD), dementia with Lewy bodies (DLB), and frontotemporal dementia;
• 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);
• Patients are unable to participate in the examination who have severe visual or auditory impairments, apraxia, aphasia, or apparent neurological abnormalities;
• Patients with communication difficulties, patients with mental illness;
• Patients with depression, Hamilton Depression Scale ( HAMD ) ≥ 17 points;
• Patients with alcohol or drug dependency diagnosed within 6 months;
• Patients with severe liver, kidney, or heart failure or other serious primary diseases;
• Preconceptional, lactating, and pregnant women

Where it is running

• Second Affiliated Hospital of Tsinghua University — Beijing, Beijing Municipality, China (enrolling)
• Qinhuangdao Hospital of Traditional Chinese Medicine — Qinhuangdao, Hebei, China (enrolling)
• Kaifeng Third People's Hospital — Kaifeng, Henan, China (enrolling)
• Shandong Public Health Clinical Center — Jinan, Shandong, China (enrolling)
• Weifang Hospital of Traditional Chinese Medicine — Weifang, Shandong, China (enrolling)
• Kunming Sanbo Brain Hospital — Kunming, Yunnan, China (enrolling)

Full record on ClinicalTrials.gov

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