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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

conventional 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (6)

Other trials for the same condition