Fufang Congrong Yizhi Capsules for cognitive impairment after brain surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.