Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
NCT ID: NCT06673602
Last Updated: 2024-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2024-11-04
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional treatment group
Conventional treatment: blood pressure control and care as according to the current guidelines
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.
FCYC group
Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Kaifeng Third People's Hospital
UNKNOWN
Second Affiliated Hospital of Tsinghua University
OTHER
Weifang Hospital of Traditional Chinese Medicine
UNKNOWN
Shandong Public Health Clinical Center
OTHER_GOV
Kunming Sanbo Brain Hospital
UNKNOWN
Qinhuangdao Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Qihui Zhang, MD. PhD
Role: STUDY_DIRECTOR
Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine
Locations
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Second Affiliated Hospital of Tsinghua University
Beijing, Beijing Municipality, China
Qinhuangdao Hospital of Traditional Chinese Medicine
Qinhuangdao, Hebei, China
Kaifeng Third People's Hospital
Kaifeng, Henan, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
Kunming Sanbo Brain Hospital
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Yu Ma
Role: primary
Wengang Wang
Role: primary
Shengyong Wang
Role: primary
Qinghua Zhang
Role: primary
Chuixian Zhou
Role: primary
Jie Ren
Role: primary
Other Identifiers
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ZW2023A005
Identifier Type: -
Identifier Source: org_study_id
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