Chinese Herbal Therapy (Qiqi Shengmai Formula) for Moyamoya Vasculopathy: The CHIMES Trial
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
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
Treatments tested in this trial
- Traditional Chinese Medicine (TCM) Treatment
- Conventional medical treatment
- TCM Placebo
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov