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NCT Number: NCT07286110

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

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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Key information

Conditions

Moyamoya Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Moyamoya Syndrome Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

180 Fenglin Road, Xuhui District, Shanghai 200032,China

Shanghai, Shanghai Municipality, 200032, China

Location contact

Ziyang He

CONTACT

[email protected]

+86 180 5073 1566

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. CT Perfusion

    Time frame: 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.

Secondary outcomes

  1. Digital Subtraction Angiography

    Time frame: Baseline, 12 months after enrollment

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

  2. Integrated Head-Neck High-Resolution Vessel Wall MRI

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

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

  3. TCM Symptom Scale

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

    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.

  4. Modified Rankin Scale (mRS)

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

    Functional outcome assessed by the Modified Rankin Scale, ranging from 0 to 6, where higher scores indicate worse functional outcome.

  5. TCM Constitution Classification

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

    Traditional Chinese Medicine constitution type assessed using a standardized TCM Constitution Classification questionnaire, categorizing participants into predefined constitution types.

  6. Montreal Cognitive Assessment (MoCA)

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

    Cognitive function assessed by the Montreal Cognitive Assessment, with total scores ranging from 0 to 30, where higher scores indicate better cognitive function.

  7. National Institutes of Health Stroke Scale (NIHSS)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhigang Yang, MD

CONTACT

[email protected]

+86 137 6122 1410

Ziyang He, MD

CONTACT

[email protected]

+86 180 5073 1566

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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