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Patients diagnosed with moyamoya vasculopathy by imaging and classified as having the Traditional Chinese Medicine (TCM) syndrome of liver-yang hyperactivity will be enrolled. On the basis of standardized Western medical management, participants will receive the standardized TCM herbal formula "Qiqi Shengmai Formula" (comprising Astragali Radix, Rehmanniae Radix Praeparata, Schisandrae Fructus, Bupleuri Radix, Paeoniae Radix Alba, and Notoginseng Radix). Structured follow-up will be conducted. By comparing endpoint indicators across different treatment regimens, the study aims to evaluate the efficacy of integrated TCM-Western medicine therapy for moyamoya vasculopathy and to generate evidence-based support for an integrated diagnostic and therapeutic model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Traditional Chinese and Conventional Medical Treatment Group | Experimental | Conventional Medical Treatment: For ischemic-type moyamoya disease, antiplatelet monotherapy with cilostazol is administered, while antiplatelet therapy is not recommended for asymptomatic patients or those with hemorrhagic-type moyamoya disease. For patients with concomitant dyslipidemia, statins and evolocumab may be added, with low-density lipoprotein cholesterol controlled to 70 mg/dL (1.8 mmol/L). Blood pressure is maintained at 140/90 mmHg, and glycemic management targets a hemoglobin A1c level of <7.0%. Traditional Chinese Medicine (TCM) Treatment: Patients receive the standardized TCM formula Qiqi Shengmai Decoction (composed of Astragali Radix, Rehmanniae Radix Praeparata, Schisandrae Fructus, Bupleuri Radix, Paeoniae Radix Alba, and Notoginseng Radix). The prescription is taken twice daily, one dose per administration, for six consecutive weeks, with each dose consumed 30 minutes after breakfast and dinner |
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| Conventional Medical -Only Treatment Group | Placebo Comparator | Conventional Medical Treatment： For ischemic-type moyamoya disease, antiplatelet monotherapy with cilostazol is administered, whereas antiplatelet therapy is not recommended for asymptomatic patients or those with hemorrhagic-type moyamoya disease. For patients with concomitant dyslipidemia, statins and evolocumab may be added, with low-density lipoprotein cholesterol controlled to 70 mg/dL (1.8 mmol/L). Blood pressure is maintained at 140/90 mmHg, and glycemic management targets a hemoglobin A1c level of <7.0%. TCM Placebo: The placebo consists primarily of medicinal starch, food-grade caramel coloring (for color correction), and a bittering agent (for flavor adjustment). Its appearance-including shape, size, color, and taste-is identical to that of the herbal preparation. It is administered twice daily, one dose at each administration, for six consecutive weeks, taken 30 minutes after breakfast and dinner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicine (TCM) Treatment | Drug | Patients receive the standardized TCM formula Qiqi Shengmai Decoction (composed of Astragali Radix, Rehmanniae Radix Praeparata, Schisandrae Fructus, Bupleuri Radix, Paeoniae Radix Alba, and Notoginseng Radix). The prescription is taken twice daily, one dose per administration, for six consecutive weeks, with each dose consumed 30 minutes after breakfast and dinner |
| Measure | Description | Time Frame |
|---|---|---|
| CT Perfusion | Cerebral perfusion parameters measured by CT perfusion imaging, including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to peak (TTP), to evaluate cerebral hemodynamics. | Baseline, at 3 months, 6 months, and 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Digital Subtraction Angiography | Cerebral angiographic characteristics assessed by digital subtraction angiography, including degree of arterial stenosis/occlusion, collateral vessel formation, and Suzuki stage. | Baseline, 12 months after enrollment |
| Integrated Head-Neck High-Resolution Vessel Wall MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziyang He, MD | Contact | +86 180 5073 1566 | heziyang0207@gmail.com | |
| Zhigang Yang, MD | Contact | +86 137 6122 1410 | yang.zhigang1@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road, Xuhui District, Shanghai 200032,China | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D009072 | Moyamoya Disease |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
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|
| Conventional medical treatment | Drug | For ischemic-type moyamoya disease, antiplatelet monotherapy with cilostazol is administered, while antiplatelet therapy is not recommended for asymptomatic patients or those with hemorrhagic-type moyamoya disease. For patients with concomitant dyslipidemia, statins and evolocumab may be added, with low-density lipoprotein cholesterol controlled to 70 mg/dL (1.8 mmol/L). Blood pressure is maintained at 140/90 mmHg, and glycemic management targets a hemoglobin A1c level of <7.0%. |
|
| TCM Placebo | Drug | The placebo consists primarily of medicinal starch, food-grade caramel coloring (for color correction), and a bittering agent (for flavor adjustment). Its appearance-including shape, size, color, and taste-is identical to that of the herbal preparation. It is administered twice daily, one dose at each administration, for six consecutive weeks, taken 30 minutes after breakfast and dinner. |
|
Intracranial arterial wall characteristics assessed by high-resolution vessel wall MRI, including vessel wall thickening, enhancement pattern, and lumen diameter. |
| Baseline, 6 months, and 12 months after enrollment |
| TCM Symptom Scale | Traditional Chinese Medicine symptom severity assessed using a standardized TCM Symptom Scale. Total score ranges from 0 to 45, with higher scores indicating more severe symptoms. | Baseline, at 3 months, 6 months, and 12 months after enrollment |
| Modified Rankin Scale (mRS) | Functional outcome assessed by the Modified Rankin Scale, ranging from 0 to 6, where higher scores indicate worse functional outcome. | Baseline, at 3 month, 6 months, and 12 months after enrollment |
| TCM Constitution Classification | Traditional Chinese Medicine constitution type assessed using a standardized TCM Constitution Classification questionnaire, categorizing participants into predefined constitution types. | Baseline, at 3 month, 6 month, and 12 months after enrollment |
| Montreal Cognitive Assessment (MoCA) | Cognitive function assessed by the Montreal Cognitive Assessment, with total scores ranging from 0 to 30, where higher scores indicate better cognitive function. | Baseline, and at 3, 6, and 12 months after enrollment |
| National Institutes of Health Stroke Scale (NIHSS) | Neurological deficit severity assessed by the National Institutes of Health Stroke Scale, with scores ranging from 0 to 42, where higher scores indicate more severe neurological deficits. | Baseline and at 3, 6, and 12 months after enrollment |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |