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

Ischemic moyamoya disease is the most common subtype of moyamoya disease in adults. This investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of Fufang Tongluo Decoction, a traditional Chinese medicine decoction, as an adjunct to aspirin and atorvastatin in adults with ischemic moyamoya disease. A total of 128 participants will be randomized 1:1 to receive Fufang Tongluo Decoction or matching placebo in addition to aspirin 100 mg and atorvastatin 10 mg daily for 3 months. The primary outcome is the treatment effectiveness rate based on cerebral perfusion staging score change on 3.0T magnetic resonance perfusion imaging. Secondary outcomes include motor function, activities of daily living, cognition, stroke scale scores, long-term clinical endpoints, and adverse events.