Actively Recruiting
Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
Led by Qinhuangdao Hospital of Traditional Chinese Medicine · Updated on 2024-11-06
200
Participants Needed
6
Research Sites
86 weeks
Total Duration
On this page
Sponsors
Q
Qinhuangdao Hospital of Traditional Chinese Medicine
Lead Sponsor
K
Kaifeng Third People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with intracerebral hemorrhage (ICH) treated using neurosurgical robot
- Diagnosed with post-stroke cognitive impairment (PSCI)
- Meet traditional Chinese medicine diagnosis of deficiency of liver and kidney and phlegm and stagnant blood obstructing meridians pattern
- Aged 18 years or older
- Any gender
- At least 2 weeks since onset of ICH
- Conscious with sufficient visual and auditory recognition to undergo neuropsychological evaluation
- Provide informed consent
You will not qualify if you...
- Diagnosed with other types of dementia besides vascular dementia, such as Alzheimer's, Lewy body dementia, or frontotemporal dementia
- Have systemic diseases affecting cognitive function, including Parkinson's disease, normal pressure hydrocephalus, brain tumor, encephalitis, thyroid dysfunction, severe anemia, syphilis, or AIDS
- Unable to participate in examination due to severe visual or auditory impairment, apraxia, aphasia, or neurological abnormalities
- Have communication difficulties or mental illness
- Have depression with Hamilton Depression Scale score 17 or higher
- Diagnosed with alcohol or drug dependency within past 6 months
- Have severe liver, kidney, or heart failure or other serious primary diseases
- Are pregnant, breastfeeding, or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Second Affiliated Hospital of Tsinghua University
Beijing, Beijing Municipality, China, 100040
Actively Recruiting
2
Qinhuangdao Hospital of Traditional Chinese Medicine
Qinhuangdao, Hebei, China, 066000
Actively Recruiting
3
Kaifeng Third People's Hospital
Kaifeng, Henan, China, 475000
Actively Recruiting
4
Shandong Public Health Clinical Center
Jinan, Shandong, China, 250102
Actively Recruiting
5
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China, 261041
Actively Recruiting
6
Kunming Sanbo Brain Hospital
Kunming, Yunnan, China, 650100
Actively Recruiting
Research Team
Q
Qihui Zhang, MD. PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here