Fufang Tongluo Decoction as an Adjunct to Aspirin and Atorvastatin for Ischemic Moyamoya Disease

NCT07875335 | Enrolling By Invitation DMC

• 1 other identifier: 2025-SR-1232
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Ischemic moyamoya disease is the most common subtype of moyamoya disease in adults. This investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of Fufang Tongluo Decoction, a traditional Chinese medicine decoction, as an adjunct to aspirin and atorvastatin in adults with ischemic moyamoya disease. A total of 128 participants will be randomized 1:1 to receive Fufang Tongluo Decoction or matching placebo in addition to aspirin 100 mg and atorvastatin 10 mg daily for 3 months. The primary outcome is the treatment effectiveness rate based on cerebral perfusion staging score change on 3.0T magnetic resonance perfusion imaging. Secondary outcomes include motor function, activities of daily living, cognition, stroke scale scores, long-term clinical endpoints, and adverse events.

Conditions

Moyomoya Disease

Keywords

Moyomoya Disease; stroke; Fufang Tongluo Placebo; ischemic moyamoya disease; traditional Chinese medicine; cerebral perfusion

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Increase of at Least 1 Point in Cerebral Perfusion Staging Score

  Cerebral perfusion is staged on 3T moyamoya MRI (non-contrast and contrast-enhanced) perfusion imaging using four parameters (time to peak, TTP; mean transit time, MTT; cerebral blood flow, CBF; cerebral blood volume, CBV), classified into 2 stages and 4 subtypes (II2, II1, I2, I1) and scored 1 to 4 as ordinal data. The percentage of participants whose perfusion staging score increases by at least 1 point after the 3-month intervention compared with baseline is calculated for each group. Images are read by radiologists blinded to group allocation.

  Baseline (before intervention) and the day after completion of the 3-month treatment course

Secondary Outcomes (7)

• Fugl-Meyer Assessment of Motor Function Score

  Baseline and the end of the 3-month intervention

• Modified Barthel Index Score

  Baseline and the end of the 3-month intervention

• Montreal Cognitive Assessment Score

  Baseline and the end of the 3-month intervention

• National Institutes of Health Stroke Scale Score

  Baseline and the end of the 3-month intervention

• Incidence of New Intracerebral Hemorrhage

  From randomization to the end of the 3-year telephone follow-up

Other Outcomes (1)

• Incidence of Adverse Events and Serious Adverse Events

  From first dose to the end of the study (including the 3-year telephone follow-up)

Study Arms (2)

Aspirin + Atorvastatin + Fufang Tongluo Decoction

EXPERIMENTAL

Aspirin (100 mg, once daily, one tablet) + Atorvastatin (10 mg, once daily, one tablet) + Fufang Tongluo Decoction (one dose each time, twice daily)

Drug: Aspirin; Drug: Atorvastatin; Drug: Fufang Tongluo Decoction

Aspirin + Atorvastatin + Fufang Tongluo Placebo

PLACEBO COMPARATOR

Aspirin (100 mg, once daily, one tablet) + Atorvastatin (10 mg, once daily, one tablet) + Placebo (one dose each time, twice daily)

Drug: Aspirin; Drug: Fufang Tongluo Placebo

Interventions

Aspirin DRUG

100 mg, once daily, one tablet

Aspirin + Atorvastatin + Fufang Tongluo Decoction; Aspirin + Atorvastatin + Fufang Tongluo Placebo

Atorvastatin DRUG

10 mg, once daily, one tablet

Aspirin + Atorvastatin + Fufang Tongluo Decoction

Fufang Tongluo Decoction DRUG

Prepared Polygonum multiflorum (He Shou Wu), Gastrodia elata (Tian Ma), Prepared Polygonatum sibiricum (Huang Jing), Fried Bombyx Batryticatus (Jiang Can), Sargassum (Hai Zao), Euonymus alatus (Gui Jian Yu) - each 10 g; Fried Hirudo (Shui Zhi) - 6 g. One dose per day, decocted in water to yield 200 mL, taken in two divided doses (morning and evening)

Aspirin + Atorvastatin + Fufang Tongluo Decoction

Fufang Tongluo Placebo DRUG

The placebo is prepared by combining 10% of the original herbal formula with rice flour and edible flavoring agents to mimic the color, taste, and consistency of the active decoction.

Aspirin + Atorvastatin + Fufang Tongluo Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years;
• Meets the Western medicine diagnostic criteria for moyamoya disease, with reference to the recommendations in the 2024 Chinese Expert Consensus on the Diagnosis and Treatment of Moyamoya Disease and Moyamoya Syndrome:
• Confirmed diagnosis of moyamoya disease (8B22.B) and stroke (A07.01.01)
• ① DSA findings: stenosis or occlusion of the terminal internal carotid artery (ICA) and/or the proximal anterior cerebral artery (ACA) and/or the proximal middle cerebral artery (MCA); appearance of abnormal vascular networks at the skull base in the arterial phase;
• ② MRI and MRA findings: stenosis or occlusion of the terminal ICA and/or proximal ACA and/or proximal MCA; presence of abnormal vascular networks in the basal ganglia region (identification of \>2 prominent flow voids in the basal ganglia on a single scan slice suggests the presence of abnormal vascular networks);
• Meets the TCM syndrome differentiation criteria for moyamoya disease: fulfills the diagnostic criteria for "stroke" of the phlegm-stasis obstructing the collaterals syndrome, accompanied by tongue signs (dark tongue with white/greasy or yellow/greasy coating) and pulse signs (wiry/slippery or thin/choppy), together with the presence of at least 2 primary symptoms, or 1 primary symptom plus 2 secondary symptoms;
• Stable baseline treatment for at least the past 1 month (e.g., antiplatelet therapy, management of atherosclerosis/hypertension/coronary heart disease; underlying conditions well controlled with no anticipated need for additional medication to manage the underlying disease during the intervention period);
• Able to understand and consent to comply with the trial requirements and restrictions.

You may not qualify if:

• Presence of 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 or hereditary central nervous system disorders, neurodevelopmental abnormalities, uncontrolled epilepsy, or other neurological conditions that, in the investigator's judgment, may significantly affect motor or cognitive function;
• Pregnant or breastfeeding patients;
• Patients with severe dysfunction of major organs such as heart, liver, kidney, or lung; patients with severe congenital malformations; patients with hematological disorders; patients with severe infections or malignancies; seropositivity for HIV, syphilis, or hepatitis B/C;
• Current participation in another drug clinical trial;
• History of intolerance or allergy to any component of the investigational product;
• Ischemic stroke occurring within \<12 months prior to enrollment; or a history of hemorrhagic moyamoya disease or other subtypes of moyamoya disease;
• Use of protocol-prohibited medications within 30 days prior to enrollment; presence of alcohol or drug dependence;
• Anticipated need for carotid or cerebrovascular surgery (including interventional procedures) during the trial period.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital (Jiangsu Provincial People's Hospital)

Nanjing, Jaingsu, 210029, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Aspirin; Atorvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Pharmacists at the research site pharmacy and the statisticians are also masked. The pharmacy dispenses blinded medication according to the drug number prompted by the Interactive Web Response System without knowledge of group assignment, and statisticians remain blinded until data cleaning and locking. The placebo matches the active decoction in appearance, color, taste, and labeling; the outer packaging shows only the trial, site, and drug numbers, with no allocation information. Emergency unblinding is permitted only for medical necessity or written request from ethics or regulatory authorities, with a complete audit trail. Imaging (perfusion staging) and functional scale assessments are performed by blinded independent raters.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Deputy Director of the Ward, Doctoral Supervisor

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: October 15, 2026
• Study Start: December 31, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)