Fufang Tongluo Decoction as an Adjunct to Aspirin and Atorvastatin for Ischemic Moyamoya Disease

Prior treatment

• Current participation in another drug clinical trial;
• History of intolerance or allergy to any component of the investigational product;
• Ischemic stroke occurring within \<12 months prior to enrollment; or a history of hemorrhagic moyamoya disease or other subtypes of moyamoya disease;
• Use of protocol-prohibited medications within 30 days prior to enrollment; presence of alcohol or drug dependence;
• Anticipated need for carotid or cerebrovascular surgery (including interventional procedures) during the trial period.

Other illness

• Presence of cognitive impairment or severe mental illness (ICD-10: F20-F48, F60-F69), such as Alzheimer's disease, other neurodegenerative diseases, Parkinson's disease, multiple sclerosis, demyelinating or hereditary central nervous system disorders, neurodevelopmental abnormalities, uncontrolled epilepsy, or other neurological conditions that, in the investigator's judgment, may significantly affect motor or cognitive function;
• Patients with severe dysfunction of major organs such as heart, liver, kidney, or lung; patients with severe congenital malformations; patients with hematological disorders; patients with severe infections or malignancies; seropositivity for HIV, syphilis, or hepatitis B/C;

Other

• Pregnant or breastfeeding patients;

• Age: 18-60 years;
• Meets the Western medicine diagnostic criteria for moyamoya disease, with reference to the recommendations in the 2024 Chinese Expert Consensus on the Diagnosis and Treatment of Moyamoya Disease and Moyamoya Syndrome:
  • Confirmed diagnosis of moyamoya disease (8B22.B) and stroke (A07.01.01)
  • ① DSA findings: stenosis or occlusion of the terminal internal carotid artery (ICA) and/or the proximal anterior cerebral artery (ACA) and/or the proximal middle cerebral artery (MCA); appearance of abnormal vascular networks at the skull base in the arterial phase;
  • ② MRI and MRA findings: stenosis or occlusion of the terminal ICA and/or proximal ACA and/or proximal MCA; presence of abnormal vascular networks in the basal ganglia region (identification of \>2 prominent flow voids in the basal ganglia on a single scan slice suggests the presence of abnormal vascular networks);
  • ③ Exclusion of other diseases that must be ruled out to confirm the diagnosis of moyamoya disease;
• Meets the TCM syndrome differentiation criteria for moyamoya disease: fulfills the diagnostic criteria for "stroke" of the phlegm-stasis obstructing the collaterals syndrome, accompanied by tongue signs (dark tongue with white/greasy or yellow/greasy coating) and pulse signs (wiry/slippery or thin/choppy), together with the presence of at least 2 primary symptoms, or 1 primary symptom plus 2 secondary symptoms;
• Stable baseline treatment for at least the past 1 month (e.g., antiplatelet therapy, management of atherosclerosis/hypertension/coronary heart disease; underlying conditions well controlled with no anticipated need for additional medication to manage the underlying disease during the intervention period);
• Able to understand and consent to comply with the trial requirements and restrictions.