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

NCT06673602 | Recruiting Phase 4

• 1 other identifier: ZW2023A005
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Cognitive Impairment; Intracerebral Hemorrhage

Keywords

Cognitive Impairment; Intracerebral Hemorrhage; robot-assisted neurosurgery treatment; Fufang Congrong Yizhi Capsules

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional treatment group

ACTIVE COMPARATOR

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

Drug: conventional treatment

FCYC group

EXPERIMENTAL

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

Interventions

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.

FCYC group

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.

Conventional treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Second Affiliated Hospital of Tsinghua University

Beijing, Beijing Municipality, 100040, China

RECRUITING

Qinhuangdao Hospital of Traditional Chinese Medicine

Qinhuangdao, Hebei, 066000, China

RECRUITING

Kaifeng Third People's Hospital

Kaifeng, Henan, 475000, China

RECRUITING

Shandong Public Health Clinical Center

Jinan, Shandong, 250102, China

RECRUITING

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, 261041, China

RECRUITING

Kunming Sanbo Brain Hospital

Kunming, Yunnan, 650100, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qihui Zhang, MD. PhD

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

  STUDY DIRECTOR

Central Study Contacts

Qihui Zhang, MD. PhD

CONTACT

+86-10-67689749; qihuizhang@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: November 5, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)