NCT06673602 Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
| NCT ID | NCT06673602 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qinhuangdao Hospital of Traditional Chinese Medicine |
| Condition | Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-11-04 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Qihui Zhang, MD. PhD
STUDY DIRECTOR
Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine
Frequently Asked Questions
Who can join the NCT06673602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06673602 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06673602 currently recruiting?
Yes, NCT06673602 is actively recruiting participants. Contact the research team at qihuizhang@vip.sina.com for enrollment information.
Where is the NCT06673602 trial being conducted?
This trial is being conducted at Beijing, China, Qinhuangdao, China, Kaifeng, China, Jinan, China and 2 additional locations.
Who is sponsoring the NCT06673602 clinical trial?
NCT06673602 is sponsored by Qinhuangdao Hospital of Traditional Chinese Medicine. The principal investigator is Qihui Zhang, MD. PhD at Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine. The trial plans to enroll 200 participants.