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Efficacy and Safety of DL-3-n-butylphthalide in Adult Patients with Moyamoya Disease after Indirect Revascularization: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Efficacy and Safety of DL-3-n-butylphthalide in Adult Patients with Moyamoya Disease after Indirect Revascularization: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104834
Enrollment
Unknown
Registered
2025-06-24
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moyamoya disease

Interventions

Experimental Group (Butylphthalide Group):After the first EDAS surgery, cranial CT examination showed no obvious intracranial hemorrhage after the operation. The medication was initiated. Oral butylph
control group:Butylphthalide is not used. The specific plan is based on the "Chinese Expert Consensus on the Treatment of Moyamoya Disease 2019" and the "Chinese Expert Consensus on the Prevention and

Sponsors

The first medical center of Chinese PLA general hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Age range: 18 to 60 years old; 2) Meet the 2021 Moyamoya disease diagnostic criteria of the Ministry of Health and Welfare of Japan; 3) No contraindications for vascular reconstruction surgery; 4) Agreeing to sign the informed consent and able to cooperate with follow-up visits; 5) Patients diagnosed with acute or subacute cerebral infarction by plain MRI scan or patients diagnosed with mild to moderate cognitive impairment by cognitive function tests (MoCA < 26 points).

Exclusion criteria

Exclusion criteria: 1) Patients with pacemakers, severe heart, lung, liver and kidney dysfunction, malignant tumors, various bleeding disorders, acute infectious diseases, high fever diseases, and those in the recovery period after heart surgery; 2) Patients with severe coagulation disorders; 3) Patients with incomplete medical records; 4) Patients who have previously undergone intracranial and extracranial vascular reconstruction surgery or endovascular treatment; 5) Patients with severe allergies to contrast agents or enhancers required for imaging examinations in the research protocol, claustrophobia, or other conditions that prevent them from cooperating with imaging examinations; 6) Patients with a possibility of cardiogenic embolism (such as atrial fibrillation, rheumatic heart disease, mitral stenosis, aortic stenosis, bacterial endocarditis, patent foramen ovale, and after artificial valve replacement, etc.); 7) Patients who have experienced severe trauma, stress, infection or undergone major surgery within the past month; 8) Pregnant or lactating women. 9) Patients allergic to celery and related drugs.

Design outcomes

Primary

MeasureTime frame
Any Stroke events and all cause mortality;Ischemic stroke events for lesion artery territory;Imaging evaluation of Revascularization (Matsushima grade based on DSA);

Secondary

MeasureTime frame
mRS scale;Cognition function evaluation;The improvement of nuclear magnetic resonance perfusion parameters (MTT, TTP, CBF, CBV);

Countries

China

Contacts

Public ContactCong Han

The first medical center of Chinese PLA general hospital

hc82225@126.com+86 176 1072 6613

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026