Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES Trial

Phase 1Not Yet RecruitingNCT07286110

Fudan University66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Moyamoya Disease Moyamoya Syndrome

Interventions

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

Conventional medical treatmentDRUG

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 PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Imaging findings meeting the Western medical diagnostic criteria for moyamoya vasculopathy 2. Age between 18 and 80 years 3. The patient and family members are fully informed and voluntarily consent to participation, with the informed consent process conducted in accordance with GCP requirements 4. Willingness to receive Traditional Chinese Medicine treatment 5. Traditional Chinese Medicine syndrome differentiation consistent with liver-yang hyperactivity Exclusion Criteria: 1. Acute cerebrovascular events within the preceding 6 weeks 2. Known allergy to contrast agents or to the investigational medication 3. Presence of severe primary diseases involving the cardiac, pulmonary, hepatic, renal, endocrine, or hematopoietic systems 4. Pregnant or breastfeeding women 5. Patients scheduled to undergo cerebral revascularization surgery 6. Participation in other ongoing clinical trial

Outcomes

Primary Outcomes

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.

Time frame: Baseline, at 3 months, 6 months, and 12 months after enrollment

Secondary Outcomes

Digital Subtraction Angiography

Cerebral angiographic characteristics assessed by digital subtraction angiography, including degree of arterial stenosis/occlusion, collateral vessel formation, and Suzuki stage.

Time frame: Baseline, 12 months after enrollment

Integrated Head-Neck High-Resolution Vessel Wall MRI

Intracranial arterial wall characteristics assessed by high-resolution vessel wall MRI, including vessel wall thickening, enhancement pattern, and lumen diameter.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and at 3, 6, and 12 months after enrollment