Effect of Chinese Herbal Intervention (Qiqi Shengmai Formula) for Moyamoya Vasculopathy in Cerebral Hemodynamics (CHIMES ): a Single-center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- CT Perfusion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imaging findings meeting the Western medical diagnostic criteria for moyamoya vasculopathy
- •Age between 18 and 80 years
- •The patient and family members are fully informed and voluntarily consent to participation, with the informed consent process conducted in accordance with GCP requirements
- •Willingness to receive Traditional Chinese Medicine treatment
- •Traditional Chinese Medicine syndrome differentiation consistent with liver-yang hyperactivity
排除标准
- •Acute cerebrovascular events within the preceding 6 weeks
- •Known allergy to contrast agents or to the investigational medication
- •Presence of severe primary diseases involving the cardiac, pulmonary, hepatic, renal, endocrine, or hematopoietic systems
- •Pregnant or breastfeeding women
- •Patients scheduled to undergo cerebral revascularization surgery
- •Participation in other ongoing clinical trial
研究组 & 干预措施
Integrated Traditional Chinese and Conventional Medical Treatment Group
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
干预措施: Traditional Chinese Medicine (TCM) Treatment (Drug)
Integrated Traditional Chinese and Conventional Medical Treatment Group
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
干预措施: Conventional medical treatment (Drug)
Conventional Medical -Only Treatment Group
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.
干预措施: Conventional medical treatment (Drug)
Conventional Medical -Only Treatment Group
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.
干预措施: TCM Placebo (Drug)
结局指标
主要结局
CT Perfusion
时间窗: Baseline, at 3 months, 6 months, and 12 months after enrollment
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.
次要结局
- Digital Subtraction Angiography(Baseline, 12 months after enrollment)
- Integrated Head-Neck High-Resolution Vessel Wall MRI(Baseline, 6 months, and 12 months after enrollment)
- TCM Symptom Scale(Baseline, at 3 months, 6 months, and 12 months after enrollment)
- Modified Rankin Scale (mRS)(Baseline, at 3 month, 6 months, and 12 months after enrollment)
- TCM Constitution Classification(Baseline, at 3 month, 6 month, and 12 months after enrollment)
- Montreal Cognitive Assessment (MoCA)(Baseline, and at 3, 6, and 12 months after enrollment)
- National Institutes of Health Stroke Scale (NIHSS)(Baseline and at 3, 6, and 12 months after enrollment)
研究者
Ziyang He
Sub-Investigator
Fudan University