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

Fudan University

Status and phase: Not yet enrolling; Phase 1

Conditions: Moyamoya Disease; Moyamoya Syndrome

Treatments: Drug: TCM Placebo; Drug: Traditional Chinese Medicine (TCM) Treatment; Drug: Conventional medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07286110

ShanghaiZhongshan

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Integrated Traditional Chinese and Conventional Medical Treatment Group

Experimental group

Description:

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

Treatment:

Drug: Conventional medical treatment

Drug: Traditional Chinese Medicine (TCM) Treatment

Conventional Medical -Only Treatment Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Conventional medical treatment

Drug: TCM Placebo