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| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Beijing Kangerfu Pharmaceutical Company Limited | UNKNOWN |
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This study aims to evaluate the effectiveness and safety of a Chinese medicine-based intervention combined with standard medicine, in reducing composite vascular events in patients with hypertensive intracerebral hemorrhage (HICH).This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 1950 participants with HICH within 7 days of onset, accompanied by imaging evidence of cerebral small vessel disease, will be enrolled.Participants will be randomly assigned to receive eitherNaoxuekang Dropping Pills or matching placebo for 90 days, in addition to guideline-based standard care.The primary outcome is the incidence of composite vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death, deep vein thrombosis, and pulmonary embolism) within 1 year.Secondary outcomes include vascular events within 90 days, neurological function (mRS), and cognitive function (MMSE, MoCA) at 90 days and 1 year.Safety will be monitored through adverse event reporting.The results will provide evidence for optimizing secondary prevention strategies in HICH patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in this group will receive Naoxuekang Dropping Pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care. |
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| Control Group | Placebo Comparator | Participants in this group will receive matched placebo pills (20 pills, three times daily) orally for 90 days, in addition to standardized guideline-based Western medical care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naoxuekang Dropping Pills | Drug | A traditional Chinese medicine. Each pill weighs 35mg. Dosage: 20 pills, three times daily, orally for 90 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Composite Vascular Events | Composite vascular events within one year of onset, including arterial vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death) and venous vascular events (lower extremity venous thrombosis, pulmonary embolism). | Within 1 year after the onset of intracerebral hemorrhage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xintong Song, MD | Contact | 010-17519241291 | Songxt1962@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qian Zhang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
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Participants are randomly assigned to one of two parallel groups: the Naoxuekang group or the placebo control group.
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| Naoxuekang Matching Placebo | Drug | A placebo pill matched to Naoxuekang Dropping Pills in appearance, taste , size, and packaging. Dosage: 20 pills, three times daily, orally for 90 days. |
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| ID | Term |
|---|---|
| D020299 | Intracranial Hemorrhage, Hypertensive |
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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