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

NCT06673602 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kaifeng Third People's Hospital

    collaborator UNKNOWN

  • Second Affiliated Hospital of Tsinghua University

    collaborator OTHER

  • Weifang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Shandong Public Health Clinical Center

    collaborator OTHER_GOV

  • Kunming Sanbo Brain Hospital

    collaborator UNKNOWN

  • Qinhuangdao Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Qihui Zhang, MD. PhD · Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673602 on ClinicalTrials.gov