Cognitive ImpairmentPhase 4NCT06673602
Fufang Congrong Yizhi Capsules (FCYC) of Cognitive Impairment After Intracerebral Hemorrhage
A Phase 4 study testing FCYC+Conventional treatment and conventional treatment in people with Cognitive Impairment and Intracerebral Hemorrhage, run by Qinhuangdao Hospital of Traditional Chinese Medicine at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Intracerebral Hemorrhage
- What is being tested?
- FCYC+Conventional treatment and conventional treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesChina
- Study dates
- 4 Nov 2024to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Second Affiliated Hospital of Tsinghua University
Beijing, Beijing Municipality, 100040
Yu Ma
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
Qinghua Zhang
- Recruiting
Kaifeng Third People's Hospital
Kaifeng, Henan, 475000
Shengyong Wang
- Recruiting
Kunming Sanbo Brain Hospital
Kunming, Yunnan, 650100
Jie Ren
- Recruiting
Qinhuangdao Hospital of Traditional Chinese Medicine
Qinhuangdao, Hebei, 066000
Wengang Wang
- Recruiting
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261041
Chuixian Zhou
About this study
Official title: Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)
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.
Read the detailed description
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
- Conditions
- Cognitive Impairment, Intracerebral Hemorrhage
- Being tested
- FCYC+Conventional treatment, conventional treatment
- Keywords
- Cognitive Impairment, Intracerebral Hemorrhage, robot-assisted neurosurgery treatment, Fufang Congrong Yizhi Capsules
- Medical subject headings
- Cognitive Dysfunction, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCYC+Conventional treatmentDrug
Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment.
conventional treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Active comparator | Conventional treatment: blood pressure control and care as according to the current guidelines Receives: Drug: conventional treatment |
| FCYC group | Experimental | Conventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment Receives: Drug: FCYC+Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA)
It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome.
Measured: at baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start4 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinhuangdao Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kaifeng Third People's Hospital, Second Affiliated Hospital of Tsinghua University, Weifang Hospital of Traditional Chinese Medicine, Shandong Public Health Clinical Center, Kunming Sanbo Brain Hospital
- Responsible party
- Sponsor
- Investigators
- Qihui Zhang, MD. PhD, Study director, Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673602
- Sponsor's protocol ID
- ZW2023A005
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fufang Congrong Yizhi Capsules (FCYC) to Cognitive Impairment After Robot-assisted Neurosurgical Management for Intracerebral Hemorrhage(CONPAIR)
- ClinicalTrials.gov ID
- NCT06673602
- Acronym / sponsor ID
- ZW2023A005
- Conditions
- Cognitive Impairment, Intracerebral Hemorrhage
- Keywords
- Cognitive Impairment, Intracerebral Hemorrhage, robot-assisted neurosurgery treatment, Fufang Congrong Yizhi Capsules
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qinhuangdao Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Kaifeng Third People's Hospital, Second Affiliated Hospital of Tsinghua University, Weifang Hospital of Traditional Chinese Medicine, Shandong Public Health Clinical Center, Kunming Sanbo Brain Hospital
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Drug: conventional treatmentConventional treatment: blood pressure control and care as according to the current guidelines |
| FCYC group | Experimental | Drug: FCYC+Conventional treatmentConventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FCYC+Conventional treatmentConventional treatment combined with oral administration of FCYC (four capsules, three times a day, orally) for a 12-week course of treatment. | Drug | FCYC group |
| conventional treatmentThe control group will receive the current gold standard treatment for ICH according to the guidelines (AHA/ASA 2022). This involves blood pressure and care. | Drug | Conventional treatment group |
Primary outcome
Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA)
Time frame: at baseline, 3 months, 6 months, 12 months
It is a widely used screening assessment for detecting cognitive impairment. Low score is worse outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qihui Zhang, MD. PhD study director
Qinhuangdao Hospital of Traditional Chinese Medicine; Dongfang Hospital of Beijing University of Chinese Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FCYC+Conventional treatment and conventional treatment in people with Cognitive Impairment and Intracerebral Hemorrhage, run by Qinhuangdao Hospital of Traditional Chinese Medicine at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qihui Zhang, MD. PhD (+86-10-67689749, qihuizhang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive functioning measured by Montreal Cognitive Assessment (MoCA) (time frame: at baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.