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RECRUITING
NCT06673602
PHASE4

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

Sponsor: Qinhuangdao Hospital of Traditional Chinese Medicine

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-11-04

Completion Date

2026-06-30

Last Updated

2024-11-06

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (6)

Second Affiliated Hospital of Tsinghua University

Beijing, Beijing Municipality, 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