drugset / Trial / NCT07286110

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

NCT07286110

Phase 1 Not yet recruiting 66 enrolled Fudan University
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2025-12-30
Primary completion
2026-11-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Qiqi Shengmai Decoction Traditional medicine (herbal / TCM) Oral
Background Cilostazol Small molecule
Background Evolocumab Monoclonal antibody

Indications