Fufang Congrong Yizhi Capsules for cognitive impairment after brain surgery
Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)
This study is testing whether Fufang Congrong Yizhi Capsules can help people with memory problems after brain surgery feel better compared to standard treatment alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qinhuangdao Hospital of Traditional Chinese Medicine Academic / other |
| Locations | 6 sites (Beijing, Beijing Municipality and 5 other locations) |
| Trial ID | NCT06673602 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness of Fufang Congrong Yizhi Capsules (FCYC) in treating cognitive impairment following robot-assisted neurosurgery for intracerebral hemorrhage (ICH). A total of 200 participants with cognitive impairment will be randomly assigned to receive either FCYC combined with conventional treatment or conventional treatment alone for 12 weeks. The study aims to evaluate the safety and efficacy of FCYC and identify factors contributing to cognitive impairment post-surgery. The use of robotic surgery is highlighted for its precision and reduced operative time compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above who have been diagnosed with intracerebral hemorrhage and post-stroke cognitive impairment.
Not a fit: Patients with other types of dementia or systemic diseases affecting cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cognitive function in patients recovering from intracerebral hemorrhage.
How similar studies have performed: Previous studies have shown positive outcomes for similar treatments in cognitive impairment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality and 5 other locations
- Second Affiliated Hospital of Tsinghua University — Beijing, Beijing Municipality, China (Recruiting)
- Qinhuangdao Hospital of Traditional Chinese Medicine — Qinhuangdao, Hebei, China (Recruiting)
- Kaifeng Third People's Hospital — Kaifeng, Henan, China (Recruiting)
- Shandong Public Health Clinical Center — Jinan, Shandong, China (Recruiting)
- Weifang Hospital of Traditional Chinese Medicine — Weifang, Shandong, China (Recruiting)
- Kunming Sanbo Brain Hospital — Kunming, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Qihui Zhang, MD. PhD
- Email: qihuizhang@vip.sina.com
- Phone: +86-10-67689749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.