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

ConditionsMoyamoya DiseaseMoyamoya Syndrome
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Integrated Traditional Chinese and Conventional Medical Treatment GroupExperimental treatment 2 interventions
Group B: Conventional Medical -Only Treatment GroupPlacebo comparator 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Digital Subtraction Angiography

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

Time frame
Baseline, 12 months after enrollment
2

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.

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

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.

Time frame
Baseline, at 3 months, 6 months, and 12 months after enrollment
4

Modified Rankin Scale (mRS)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: