An interventional study of Daphnetin Capsule and Placebo in Cerebrovascular Disorders, sponsored by First People's Hospital of Shenyang. Recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by First People's Hospital of Shenyang · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to understand and evaluate the clinical efficacy and safety of Daphnetin Capsule in patients with vascular cognitive impairment. Changes in the Vascular Dementia Assessment Scale-cog(VADAS-cog) at 6 months were evaluated. Although Daphnetin has a dual neurovascular protective effect, however, there is still a lack of relevant high-quality studies on its role in patients with vascular cognitive impairment, especially in patients with vascular cognitive impairment in non-dementia (VCI-ND), whether it has a role in improving cognitive status needs to be urgently explored in high-quality clinical studies. Researchers are comparing Daphnetin to placebo (a drug-free analog) to see if Daphnetin is effective in treating vascular cognitive impairment. Participants will take either Daphnetin or placebo daily for six months, with follow-up visits every three months and completion of a case report form.
Vascular cognitive impairment (VCI) is caused by ischemic or hemorrhagic strokes and other cerebrovascular diseases, leading to cognitive and memory function impairment. With the aging population and high incidence of cerebrovascular diseases in China, Vascular cognitive impairment (VCI) prevalence is rising, increasing the disease burden. However, due to the complexity of Vascular cognitive impairment (VCI) symptoms and imaging changes, targeted therapies are currently lacking.
Daphnetin, a coumarin derivative, has shown promise in treating various diseases and has gained significant attention recently. It offers "triple protection" for blood, blood vessels, and ischemic tissues by inhibiting inflammation, anticoagulation, and thrombosis, protecting endothelial structures, and regulating vasoactive substances. Daphnetin is particularly beneficial for cardio-cerebral vascular disease, diabetes mellitus, and microvascular complications. It also expands peripheral blood vessels, improving circulation and alleviating vascular occlusive diseases.
Research indicates that Daphnetin's anti-inflammatory effects can inhibit neuroinflammation, promote synaptic growth, and enhance neuronal survival, protecting nerve cells and repairing damage. Despite these benefits, there is a lack of high-quality studies on Daphnetin's role in non-dementia vascular cognitive impairment (VCI-ND).
This project aims to evaluate the clinical efficacy and safety of oral Daphnetin capsules in treating Vascular cognitive impairment (VCI) through a prospective, randomized, double-blind, placebo-controlled study. Patients with vascular cognitive dysfunction confirmed by cerebral small vessel disease imaging will participate. The study will follow the international FINESSE framework, comparing Daphnetin to a placebo over six months, with follow-up visits and case report forms completed every three months.
449 studies on the registry are indexed under Cerebrovascular Disorders; 127 are open to participants now.
This study's planned enrollment of 206 is above the median of 100 across 274 interventional studies indexed under Cerebrovascular Disorders.
Browse Cerebrovascular Disorders studies →First People's Hospital of Shenyang is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral Daphnetin Capsule three capsules/tid for up to six months.
Drug: Daphnetin Capsule
oral Placebo (Daphnetin Capsule simulants) three capsules/tid for up to six months.
Drug: Placebo
Daphnetin, chemically known as 7,8-dihydroxycoumarin, also known as ZuShiMaJiaSu, is a class of coumarin derivatives derived from different Daphnetin genus plant .
Also known as: 7,8-dihydroxycoumarin
The placebo is a Daphnetin Capsule simulants
Changes in Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog)
Vascular Dementia Assessment Scale-cognitive subscale（VADAS-cog） is a revision of the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) to be a better measure in vascular conditions，The lowest score is 0, with higher scores representing higher levels of cognitive dysfunction and poorer status of the patient.
Time frame: 6 months
Incidence of combined endpoints: including new stroke (ischemic Trial of ORG 10172 in Acute Stroke Treatment typing [TOAST typing] or hemorrhagic)/transient ischemic attack, myocardial infarction, new-onset dementia, death
For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis.
Time frame: 6 months
Incidence of each individual event of the combined endpoint
For categorical indicators, the stratified Cochran- Mantel-Haenszel (CMH) test will be used for analysis.
Time frame: 6 months
Clinician Interview-Based studies Impression of Change scale-plus version(CIBIC-Plus) of change
Consists of three parts The clinician's impression of change is an assessment of change from baseline, not an assessment of severity. The clinician may refer to his/her own baseline information compiled in Part I when making the assessment of change. The clinician's assessment of impression of change should then be replicated in the main study case report form.The score of CIBIC-plus ranges from 1 to 7, and the score of 1-3 indicates improvement, 4 means no changed, and 5-7 indicates worse.
Time frame: 6 months
Change in the Brief Mental State Evaluation Scale (MMSE)
Each correct item is scored as 1 point, and errors are scored as 0 points. The total score ranges from 0 to 30, and the cut-off value for normal and abnormal is related to the level of education; ≤17 points for the illiterate (no education) group, ≤20 points for the elementary school (≤6 years of education) group, and ≤24 points for the secondary school or above (\>6 years of education) group. Cognitive deficits are considered to be below the cut-off value and normal above it.
Time frame: 6 months
Change in the Montreal Cognitive Assessment Scale (MoCA)
The MoCA scale is a 30-point scale, with ≥26 normal, 18-26 mild cognitive impairment (MCI), 10-17 moderate, and less than 10 severe.Patients with MCI scored approximately 22 (19-25) points, and patients with AD scored between 11-21 points.
Time frame: 6 months
Changes in the Symbol Digit Transformation Test (SDMT)
Completion of the SDMT scale within 90 seconds, with a total score of 0-110; the lower the score, the more severe the degree of cognitive impairment
Time frame: 6 months
Change in Clinical Dementia Rating Scale (CDR)
The total score ranges from 0 to 18,The higher the score, the more demented the patient is, the worse the state is.
Time frame: 6 months
Change in Neuropsychiatric Questionnaire (NPI-Q)
Presence of symptoms (1-2): 1=present 2=absent. Frequency (1-4 points): 1=occasional, less than weekly; 2=frequent, about weekly; 3=several times a week but less than daily; 4=very frequent, once or more at a time or continuously. Severity (on a scale of 1 to 3): 1=mild, perceptible but not obvious; 2=moderate, obvious but not very prominent; 3=severe, very prominent changes. The degree of distress caused by the symptom to the caregiver (0-5 points): 0 = no distress; 1 = very mild distress, caregiver does not need to take steps to cope; 2 = mild distress, caregiver copes easily; 3 = moderate distress, caregiver struggles to cope; 4 = severe, caregiver is barely able to cope; 5 = extreme distress, caregiver is unable to cope. The higher the score the more severe
Time frame: 6 months
Changes in the Activities of Daily Living Scale (ADL)
1 = can do it all by myself; 2 = can still do it with some difficulty; 3 = need help 4 = cannot do it at all. When the patient never does it but is able to do it, it is rated as 1, never does it but has difficulty doing it but does not need help, 2, never does it but needs help, 3, never does it and is unable to do it, 4. The range of scores is from 20 to 80, and a score of \>23 is considered to be cognitively impaired.
Time frame: 6 months
Changes in motor function (TUG, time to walk three meters)
Change in motor score (TUG, time to walk three meters) at 6 months relative to baseline
Time frame: 6 months
EuroQol Five Dimensions Questionnaire (EQ-5D)
The EuroQol Five Dimensions Questionnaire (EQ-5D) health description system consists of five dimensions: mobility (MO), self-care (SC), ability to perform activities of daily living (UA), pain or discomfort (PD), and anxiety or depression (AD), each of which can be reported separately as "no problem, moderate problem, or severe problem".Self-rated health on a scale of 0 to 100, the higher the score the better your health is considered to be.
Time frame: 6 months
Plan to share: Yes
Ran from Jul 2025 to primary completion in Jul 2025, 0 months.
Of 96 non-industry interventional studies with no phase under Cerebrovascular Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 68. This study's 0 months is below that.
Counting every sponsor, half of 111 studies reached it within 30 months; a quarter within 14 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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First People's Hospital of Shenyang