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

NCT ID: NCT06673602

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cognitive Impairment Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional treatment group

Conventional treatment: blood pressure control and care as according to the current guidelines

Group Type ACTIVE_COMPARATOR

conventional treatment

Intervention Type 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.

FCYC group

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

Group Type EXPERIMENTAL

FCYC+Conventional treatment

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaifeng Third People's Hospital

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital of Tsinghua University

OTHER

Sponsor Role collaborator

Weifang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Shandong Public Health Clinical Center

OTHER_GOV

Sponsor Role collaborator

Kunming Sanbo Brain Hospital

UNKNOWN

Sponsor Role collaborator

Qinhuangdao Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qihui Zhang, MD. PhD

Role: STUDY_DIRECTOR

Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine

Locations

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Second Affiliated Hospital of Tsinghua University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Qinhuangdao Hospital of Traditional Chinese Medicine

Qinhuangdao, Hebei, China

Site Status RECRUITING

Kaifeng Third People's Hospital

Kaifeng, Henan, China

Site Status RECRUITING

Shandong Public Health Clinical Center

Jinan, Shandong, China

Site Status RECRUITING

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, China

Site Status RECRUITING

Kunming Sanbo Brain Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qihui Zhang, MD. PhD

Role: CONTACT

+86-10-67689749

Facility Contacts

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Yu Ma

Role: primary

Wengang Wang

Role: primary

Shengyong Wang

Role: primary

Qinghua Zhang

Role: primary

Chuixian Zhou

Role: primary

Jie Ren

Role: primary

Other Identifiers

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ZW2023A005

Identifier Type: -

Identifier Source: org_study_id

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