DL-3-n-butylphthalide Therapy for Cerebral Hypoperfusion in Unilateral Internal Carotid System Stenosis (BUTCH): A Clinical Multiple-center Study

Conditions

Cerebral hypoperfusion

Chen D, Chang X, Pan B, Li Y, Qiu F, Tang Y, Gao X, Yin Y, Yang F, Wang Y, Zhang J, Wang M, Zhu Z, Guo Y, Sun D, Tian W, Yu H, Wei Y, Yu Y, Zhao Y, Sun M, Hou Y, Li H, Wu S, Li X, Ma X, Huang F, Yan X, Wu J, Wang F, Liu K, Lin J, Wang C, Zhu H, Pan X, Chang J, Zhang B, Zhu X, Huang B, Dong X, Dai H, He J, Ma Q, Wang W, Yang Q, Cao L, Yan B, Shi J.

2026-04-30

10.1007/s40263-026-01293-w

A randomized, double-blind, placebo-controlled, multicenter trial- DL-3-n-butylphthalide therapy for cerebral hypoperfusion from unilateral internal carotid system stenosis study: study protocol

Dawei Chen, Yanwei Yin, Shi Jin, MA Xiao-xuan, Huiping Shi et al. (8 authors)

International Journal of Clinical Trials2023-01-23

10.18203/2349-3259.ijct20230052

Interventions

Control group:Butylphthalide soft capsule placebo

Intervention group:0.2g butylphthalide soft capsule

Eligibility

Sex/Gender

All

Age

35 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Aged 35 to 85 years; 2.Magnetic resonance angiography (MRA), computed tomography angiography (CTA) or digital subtraction angiography (DSA) showed severe stenosis (>= 70%) or occlusion of unilateral internal carotid artery system (internal carotid artery or M1 segment of middle cerebral artery). 3.No transient ischemic attack (TIA) or stroke occurred within 2 weeks; 4.CTP showed hypoperfusion in the middle cerebral artery supplying area on the stenosis side; 5.The patient voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.There is >= 50% stenosis of the internal carotid artery or middle cerebral artery on the opposite side, and >= 50% stenosis of the common carotid artery or innominate artery on both sides; 2.Patients who want to undergo carotid artery or other cerebrovascular stent or carotid endarterectomy or intracranial surgery; 3.There was a single cerebral infarction area >= 10mm in the blood supply area of the middle cerebral artery; 4.Other diseases affecting CTP (brain tumor, traumatic brain injury, brain infection, degeneration, heredity, etc.); 5.Receive NBP or vasodilators within 30 days; 6.Pregnant women or women who are breastfeeding; 7.Severe heart, respiratory, digestive, tumor and other systemic diseases, survival time less than 6 months; 8.Liver and kidney function is obviously abnormal, namely ALT or AST >= 3 times the upper limit of normal value, or creatinine >= 140 umol/L; 9.Cerebral artery stenosis caused by arterial dissection, active vasculitis, moyamoya disease and other diseases; 10.Patients who have a history of allergy to celery or butylphthalide; 11.Have participated in or are participating in other intervention-related clinical studies within 3 months prior to the date of informed consent; 12.Other conditions considered unsuitable for inclusion by the researcher.

Design outcomes

Primary

Measure	Time frame
Cerebral blood volume;	—

Countries

China

Contacts

Public ContactShi Jin

sjsj9@sohu.com+86 15611161112

Outcome results

None listed