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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Moyamoya Disease; Moyamoya Syndrome
• Intervention / Treatment: Drug: Traditional Chinese Medicine (TCM) Treatment; Drug: Conventional medical treatment; Drug: TCM Placebo

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ziyang He, MD; Phone Number: +86 180 5073 1566; Email: heziyang0207@gmail.com
• Study Contact Backup: Name: Zhigang Yang, MD; Phone Number: +86 137 6122 1410; Email: yang.zhigang1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • 180 Fenglin Road, Xuhui District, Shanghai 200032,China
      • Contact: Ziyang He; Phone Number: +86 180 5073 1566; Email: heziyang0207@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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%.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Moyamoya Disease; Complementary Therapies; Medicine, East Asian Traditional; Medicine, Traditional; Therapeutics; Medicine, Chinese Traditional
• Other Study ID Numbers: ShanghaiZhongshan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No