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

Официальное название

Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)

Обзор

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.

Подробное описание

The mortality and disability rate for intracerebral hemorrhage (ICH) is high, which places a severe burden on both families and society. Robot-assisted neurosurgery is a significant advancement in the development of minimally invasive surgery for ICH. Compared to conventional surgery, the advantages of robotic surgery include precise positioning, a shorter operative time, and greater stability. Cognitive impairment is a common comorbidity in patients with ICH, which significantly affects their daily life. The effectiveness of Fufang Congrong Yizhi Capsules (FCYC) in treating vascular dementia (VaD) and vascular cognitive impairment (VCI) is well established and has been documented in guidelines and expert consensus. So the primary objective of this clinical study is to observe the safety and efficacy of Fufang Congrong Yizhi Capsules (FCYC) of cognitive impairment after robot-assisted neurosurgery treatment for intracerebral hemorrhage

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA) [Срок оценки: at baseline, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• Meet the diagnostic criteria of intracerebral hemorrhage (ICH) and use a neurosurgical robot to treat ICH;
• Meet diagnostic criteria for post-stroke cognitive impairment (PSCI);
• Meet traditional Chinese medicine (TCM) diagnosis of deficiency of the liver and kidney, phlegm and stagnant blood obstructing the meridians pattern;
• Aged 18 and above;
• Not limit gender;
• 2 weeks after the onset of ICH;
• The participants are conscious, possess sufficient visual and auditory recognition, and are capable of undergoing neuropsychological evaluation;
• Submit informed consent.

Критерии исключения

• Other types of dementia besides vascular dementia (VD), such as Alzheimer's disease(AD), dementia with Lewy bodies (DLB), and frontotemporal dementia;
• 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);
• Patients are unable to participate in the examination who have severe visual or auditory impairments, apraxia, aphasia, or apparent neurological abnormalities;
• Patients with communication difficulties, patients with mental illness;
• Patients with depression, Hamilton Depression Scale ( HAMD ) ≥ 17 points;
• Patients with alcohol or drug dependency diagnosed within 6 months;
• Patients with severe liver, kidney, or heart failure or other serious primary diseases;
• Preconceptional, lactating, and pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Second Affiliated Hospital of Tsinghua University — Пекин
• Qinhuangdao Hospital of Traditional Chinese Medicine — Qinhuangdao
• Kaifeng Third People's Hospital — Kaifeng
• Shandong Public Health Clinical Center — Цзинань
• Weifang Hospital of Traditional Chinese Medicine — Weifang
• Kunming Sanbo Brain Hospital — Куньмин

Идентификаторы

NCT: NCT06673602 · ZW2023A005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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