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

Phase I Interventional Moyamoya Disease Moyamoya Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional Chinese Medicine (TCM) Treatment, Conventional medical treatment, TCM Placebo.
Who it may be relevant to
Registry conditions: Moyamoya Disease, Moyamoya Syndrome. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Chinese Herbal Intervention (Qiqi Shengmai Formula) for Moyamoya Vasculopathy in Cerebral Hemodynamics (CHIMES ): a Single-center, Prospective, Randomized Controlled Study

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.

Interventions

  • Drug 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
  • Drug 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%.
  • Drug 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.

Primary outcome measures

  • CT Perfusion [Time frame: Baseline, at 3 months, 6 months, and 12 months after enrollment]
Secondary outcome measures (7)
  • Digital Subtraction Angiography [Time frame: Baseline, 12 months after enrollment]
  • Integrated Head-Neck High-Resolution Vessel Wall MRI [Time frame: Baseline, 6 months, and 12 months after enrollment]
  • TCM Symptom Scale [Time frame: Baseline, at 3 months, 6 months, and 12 months after enrollment]
  • Modified Rankin Scale (mRS) [Time frame: Baseline, at 3 month, 6 months, and 12 months after enrollment]
  • TCM Constitution Classification [Time frame: Baseline, at 3 month, 6 month, and 12 months after enrollment]
  • Montreal Cognitive Assessment (MoCA) [Time frame: Baseline, and at 3, 6, and 12 months after enrollment]
  • National Institutes of Health Stroke Scale (NIHSS) [Time frame: Baseline and at 3, 6, and 12 months after enrollment]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • 180 Fenglin Road, Xuhui District, Shanghai 200032,China — Shanghai

Identifiers

NCT: NCT07286110 · ShanghaiZhongshan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗