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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Intracerebral Hemorrhage
• Intervention / Treatment: Drug: conventional treatment; Drug: FCYC+Conventional treatment

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qihui Zhang, MD. PhD; Phone Number: +86-10-67689749; Email: qihuizhang@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100040
      • Recruiting
      • Second Affiliated Hospital of Tsinghua University
      • Contact: Yu Ma
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • Recruiting
      • Qinhuangdao Hospital of Traditional Chinese Medicine
      • Contact: Wengang Wang
  • Henan
    • Kaifeng, Henan, China, 475000
      • Recruiting
      • Kaifeng Third People's Hospital
      • Contact: Shengyong Wang
  • Shandong
    • Jinan, Shandong, China, 250102
      • Recruiting
      • Shandong Public Health Clinical Center
      • Contact: Qinghua Zhang
    • Weifang, Shandong, China, 261041
      • Recruiting
      • Weifang Hospital of Traditional Chinese Medicine
      • Contact: Chuixian Zhou
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Recruiting
      • Kunming Sanbo Brain Hospital
      • Contact: Jie Ren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment group; Conventional treatment: blood pressure control and care as according to the current guidelines	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.
Experimental: FCYC group; Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA)	It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome.	at baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Qinhuangdao Hospital of Traditional Chinese Medicine
• Collaborators: Shandong Public Health Clinical Center; Weifang Hospital of Traditional Chinese Medicine; Second Affiliated Hospital of Tsinghua University; Kaifeng Third People's Hospital; Kunming Sanbo Brain Hospital
• Investigators: Study Director: Qihui Zhang, MD. PhD, Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: November 2, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Intracerebral Hemorrhage; robot-assisted neurosurgery treatment; Fufang Congrong Yizhi Capsules
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Intracranial Hemorrhages; Cognitive Dysfunction; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: ZW2023A005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No