Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06673602

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Second Affiliated Hospital of Tsinghua University, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

FCYC+Conventional treatment

Drug

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

Conventional Treatment

Drug

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.

Primary outcomes

  1. Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA)

    Time frame: at baseline, 3 months, 6 months, 12 months

    It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Qihui Zhang, MD. PhD

CONTACT

[email protected]

+86-10-67689749

Sponsors and collaborators

Lead sponsor

Qinhuangdao Hospital of Traditional Chinese Medicine

Other

Collaborators

  • Kaifeng Third People's Hospital
  • Kunming Sanbo Brain Hospital
  • Second Affiliated Hospital of Tsinghua University
  • Shandong Public Health Clinical Center
  • Weifang Hospital of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.