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Fufang Tongluo Decoction as an Adjunct to Aspirin and Atorvastatin for Ischemic Moyamoya Disease
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
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.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Fufang Tongluo Decoction as an Adjunct to Aspirin and Atorvastatin in the Treatment of Ischemic Moyamoya Disease
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2024-12-31
Completion Date
2027-06-30
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Aspirin
100 mg, once daily, one tablet
Atorvastatin
10 mg, once daily, one tablet
Fufang Tongluo Decoction
Prepared Polygonum multiflorum (He Shou Wu), Gastrodia elata (Tian Ma), Prepared Polygonatum sibiricum (Huang Jing), Fried Bombyx Batryticatus (Jiang Can), Sargassum (Hai Zao), Euonymus alatus (Gui Jian Yu) - each 10 g; Fried Hirudo (Shui Zhi) - 6 g. One dose per day, decocted in water to yield 200 mL, taken in two divided doses (morning and evening)
Fufang Tongluo Placebo
The placebo is prepared by combining 10% of the original herbal formula with rice flour and edible flavoring agents to mimic the color, taste, and consistency of the active decoction.
Locations (1)
Jiangsu Province Hospital (Jiangsu Provincial People's Hospital)
Nanjing, Jaingsu, China