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

NCT07286110 | Not Yet Recruiting Phase 1

• 1 other identifier: ShanghaiZhongshan
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moyamoya Disease; Moyamoya Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Integrated Traditional Chinese and Conventional Medical Treatment Group

EXPERIMENTAL

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; Drug: Conventional medical treatment

Conventional Medical -Only Treatment Group

PLACEBO COMPARATOR

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; Drug: TCM Placebo

Interventions

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

Integrated Traditional Chinese and Conventional Medical Treatment Group

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%.

Conventional Medical -Only Treatment Group; Integrated Traditional Chinese and Conventional Medical Treatment Group

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.

Conventional Medical -Only Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

180 Fenglin Road, Xuhui District, Shanghai 200032,China

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Medicine, Chinese Traditional; Therapeutics

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies

Central Study Contacts

Ziyang He, MD

CONTACT

+86 180 5073 1566; heziyang0207@gmail.com

Zhigang Yang, MD

CONTACT

+86 137 6122 1410; yang.zhigang1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)