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ENROLLING BY INVITATION

NCT07894640

EARLY_PHASE1

Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

Moyamoya disease is a relatively rare chronic cerebrovascular disease, and its exact cause is currently unknown. This disease is characterized by the gradual narrowing or even blockage of important blood vessels in the brain (the terminal portion of the internal carotid artery), while simultaneously forming an abnormal network of small blood vessels at the base of the brain. In cerebral angiography, these abnormal vessels appear as a cloud of "smoke," hence the name "Moyamoya disease." Patients with Moyamoya disease often present with cerebral hemorrhage or cerebral infarction as the initial manifestation, which can seriously affect their quality of life and even endanger their lives. In recent years, with the development of imaging examinations (such as CT, MRI, and cerebral angiography), more and more patients are being diagnosed in a timely manner. However, because the cause is still unclear, there is currently no specific drug to cure the disease. Clinically, medication is mainly used to prevent thrombosis and stabilize blood vessels, such as commonly used... Aspirin and atorvastatin are used to reduce the risk of cerebral infarction or cerebral hemorrhage and slow the progression of the disease. Currently, the main treatment for Moyamoya disease remains surgery (revascularization surgery), which aims to reduce seizures by improving blood supply to the brain. However, surgery has certain limitations, such as being technically challenging, carrying high risks, and potentially leading to postoperative complications, and it still cannot completely stop disease progression. In Traditional Chinese Medicine (TCM) theory, Moyamoya disease is often associated with "phlegm and dampness" and "blood stasis." Simply put, "phlegm and dampness" and "poor blood circulation" in the body affect the normal blood supply and function of the brain, leading to blood vessel blockage or rupture and bleeding. Therefore, TCM treatment typically focuses on \*\*"promoting blood circulation and removing blood stasis, clearing heat and cooling blood, and unblocking the meridians and opening the orifices"\*\*. "Liangxue Tongyu Fang" is a traditional Chinese medicine formula primarily used to improve hemorrhagic cerebrovascular diseases. Through the combined effects of various Chinese herbs, this formula may help improve blood circulation, reduce vascular damage, and promote brain function recovery. Currently, this formula has been used in some hemorrhagic encephalopathy cases and has shown certain therapeutic effects. This study will use clinical research methods to observe the safety (whether it will produce significant adverse reactions) and effectiveness (whether it helps improve the condition or reduce recurrence) of "Liangxue Tongyu Fang" in patients with hemorrhagic moyamoya disease, in order to provide more new options and evidence for the treatment of moyamoya disease.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-31

Completion Date

2027-06-30

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Moyamoya Disease

Interventions

DRUG

Atorvastatin

10 mg, once daily, one tablet

DRUG

Blood-cooling and Stasis-clearing Formula

200ml per dose, twice a day, one dose each time. (Formula agreed upon by Nanjing Municipal Hospital of Traditional Chinese Medicine) Blood-cooling and Stasis-clearing Formula: Ingredients include 10g of prepared rhubarb, 30g of buffalo horn (decocted first), 20g of raw rehmannia root, 15g of red peony root, 10g of peony bark, and 10g of acorus tatarinowii rhizome. Decoct in 200mL of water. Begin taking the medicine at 8:00 AM the day after diagnosis, twice a day, for a course of 12 weeks. (If coughing or other symptoms prevent oral administration, administer via nasogastric tube.)

DRUG

Blood-cooling and Stasis-clearing Formula Placebo

The original prescription was mixed with 10% rice and edible flavorings to create a placebo with similar color, taste, and properties. One dose was 200ml, taken twice a day. This was a pre-agreed prescription from Nanjing Municipal Hospital of Traditional Chinese Medicine.

Inclusion Criteria: * a) Age: 18-60 years old; b) Meets the Western medical diagnostic criteria for Moyamoya disease. Refer to the recommendations in the "Chinese Expert Consensus on the Diagnosis and Treatment of Moyamoya Disease and Moyamoya Syndrome (2024 Edition)": The diagnosis was confirmed as Moyamoya disease (8B22.B) and stroke (A07.01.01). * DSA findings include: stenosis or occlusion of the distal ICA and/or the initial segments of the ACA and/or MCA; abnormal vascular network at the base of the skull in the arterial phase; * MRI and MRA findings: stenosis or occlusion of the terminal segment of the ICA and/or the initial segment of the ACA and/or MCA; abnormal vascular network in the basal ganglia (more than 2 obvious flow voids in the basal ganglia on one scan plane, suggesting the presence of an abnormal vascular network); ③ Excluding other subtypes of Moyamoya disease that have been diagnosed as Moyamoya disease; c) Traditional Chinese Medicine diagnostic criteria for Moyamoya disease: It meets the diagnostic criteria for "stroke" with phlegm and blood stasis obstructing the collaterals, and has a dark tongue, white or yellow greasy coating, wiry or slippery or thin and hesitant pulse, etc., and has 2 or more main symptoms or 1 main symptom + 2 secondary symptoms to be diagnosed. d) The basic treatment has remained stable for nearly one month, and no additional medication is needed; e) Can understand and agree to comply with the testing requirements and limitations. Exclusion Criteria: \- 1. Individuals with coexisting cognitive impairment or severe mental illness (ICD-10: F20-F48, F60-F69), such as Alzheimer's disease, other neurodegenerative diseases, Parkinson's disease, multiple sclerosis, demyelinating/hereditary central nervous system diseases, neurodevelopmental abnormalities, uncontrollable epilepsy, and other neurological diseases that researchers judge to significantly affect motor or cognitive function; 2. Pregnant women and breastfeeding patients; 3. Individuals with severe dysfunction of organs such as the heart, liver, kidneys, and lungs; individuals with severe congenital malformations (including congenital encephalocele, congenital hydrocephalus, congenital spina bifida, Argyll syndrome, etc., and congenital heart diseases with obvious circulatory and respiratory symptoms such as ventricular septal defect, tetralogy of Fallot, etc.); individuals with hematologic disorders; individuals with severe infections, tumors, etc.; individuals with positive HIV/syphilis/hepatitis B/C serological tests; 4. Currently participating in other drug clinical trials; 5. History of intolerance/allergy to any component of the investigational drug; 6. Hemorrhagic stroke within 12 months prior to enrollment; or a history of infarct-type moyamoya disease or other types of moyamoya disease; 7. Use of medications prohibited under this protocol within 30 days prior to enrollment; presence of alcohol or drug dependence; 8. Carotid/cerebrovascular surgery (including interventional treatment) may be required during the trial.

Locations (1)

Jiangsu Province Hospital (Jiangsu Provincial People's Hospital)

Nanjing, Jiangsu, China

Clinical Research Directory

Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)