An Early Phase 1 interventional study of Atorvastatin and Replenishing Five Herbs Decoction in Moyamoya Disease, sponsored by The First Affiliated Hospital with Nanjing Medical University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Early Phase 1, Interventional, and Treatment
Moyamoya disease, also known as "smoky vein disease," is a relatively rare chronic form of cerebral artery occlusion. The exact cause of this condition is currently unknown. It is characterized by progressive blockage of the carotid arteries with the formation of an abnormal cerebral vascular network, which appears as "smoky" on cerebral angiography. In recent years, the prevalence of smoky vein disease has been increasing due to the widespread availability of various imaging techniques. Because the cause of smoky vein disease is not yet understood, there is currently no definitive and effective treatment. Management focuses primarily on addressing symptoms of ischemia and bleeding. Therefore, the current clinical approach to smoky vein disease relies heavily on surgery to restore blood flow. While surgery is believed to reduce the risk of ischemic injury, it cannot prevent stroke in either bleeding or ischemic cases.
Atypical cerebral infarction, also known as cerebral infarction syndrome, differs from typical cerebral infarction in terms of its etiology, affected areas, and clinical presentation. Unlike typical cerebral infarction, which often has an unknown cause and involves both sides of the cerebral vasculature, atypical cerebral infarction is typically caused by identifiable conditions such as atherosclerosis, autoimmune diseases (e.g., lupus), or post-stroke infection or radiation therapy. Furthermore, the vascular involvement may be limited to one side, or the angiographic findings may not fully conform to the typical presentation. In children, symptoms often include signs of cerebral ischemia (e.g., recurrent headaches, weakness), while adults may experience cerebral infarction or hemorrhage. Diagnosis relies primarily on imaging studies such as angiography.
Replenishing Five Herbs Decoction is a commonly used traditional Chinese medicine formula in clinical practice. Its key ingredients include Astragalus, Red Atractylocarpus, and Angelica sinensis. Its primary functions are to tonify Qi, promote blood circulation, and clear stagnation. It is particularly effective in treating stroke, where it demonstrates good results in cases of hemiplegia, facial asymmetry, and facial paralysis. Furthermore, Replenishing Five Herbs Decoction is also effective in treating frequent urination, urinary incontinence, and cerebrovascular diseases, including those resulting from cerebrovascular damage or coronary heart disease. Finally, it is also effective in treating muscle atrophy or paralysis caused by Qi deficiency and blood stagnation.
"Replenishing Five Herbs Decoction" has been shown to improve neurological and motor function in stroke patients, leading to better outcomes. This is likely due to the specific ingredients in the formula: ginseng, angelica root, and chuanxiong, all of which have properties that support and strengthen the body's vital energy. Additionally, the inclusion of red peony, chuanxiong, and peach kernel contributes to improved circulation and blood flow. Finally, the inclusion of Chinese yam promotes healthy circulation and overall well-being. The combination of these ingredients works synergistically to significantly improve the overall prognosis for patients with stroke."
62 studies on the registry are indexed under Moyamoya Disease; 30 are open to participants now.
This study's planned enrollment of 300 is above the median of 63 across 32 interventional studies indexed under Moyamoya Disease.
Browse Moyamoya Disease studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
a) Age: 18-60 years old b) Meet the Western medical diagnostic criteria for chronic bronchitis. Refer to the recommendations in the "Chinese Expert Consensus on Diagnosis and Treatment of Chronic Bronchitis and Chronic Respiratory Syndrome (2024 Edition)." Confirmed diagnosis of (8B22.B) and stroke (A07.01.01).
DSA findings: Narrowing or occlusion at the ICA terminus and/or ACA and/or MCA origin; abnormal dural vascular network in the arterial phase.
MRI and MRA findings: Narrowing or occlusion of the ICA terminus and/or ACA and/or MCA starting segment; abnormal vascular network in the basal ganglia region (presence of more than two distinct vascular dark spaces in the basal ganglia region on a single scan).
When excluding smog-related diagnoses, other relevant conditions must also be ruled out.
c) Criteria for diagnosing "Smog-Induced Illness" according to Traditional Chinese Medicine: Diagnosis is made based on the criteria for "Wind-Cold-Dampness-Stagnation" syndrome, including signs such as a dark tongue, white and greasy or yellow tongue coating, and a string-like or fine and dry pulse. A diagnosis is confirmed when there are at least two primary symptoms or one primary symptom plus two secondary symptoms.
d) The patient's basic condition has remained stable for the past month, and no additional medications are required.
e) Able to understand and agree to comply with the testing requirements and limitations.
Exclusion Criteria:
1. Individuals with a combined diagnosis of cognitive impairment or severe mental illness (ICD-10: F20-F48, F60-F69), such as Alzheimer's disease, other neurodegenerative conditions, Parkinson's disease, multiple sclerosis, demyelinating/hereditary central nervous system disorders, neurodevelopmental disorders, and uncontrolled epilepsy, as well as other neurological conditions that researchers determine significantly impair motor or cognitive function.
2. Pregnant women and women breastfeeding 3. Individuals with severe impairment of cardiac, liver, kidney, and lung function; patients with severe congenital abnormalities; individuals with blood system disorders; those with severe infections, tumors, or other serious illnesses; individuals testing positive for , syphilis, or /C.
4. Currently participating in other drug clinical trials. 5. History of intolerance or allergy to any component of the drug.
6. Prior stroke (within \<12 months); or a history of hemorrhagic stroke and/or other types of stroke; 7. Do not use this program within 30 days of entering a rehabilitation program; have a history of alcohol or drug dependence.
8. Surgical procedures involving the neck or blood vessels (including interventional procedures) are required during the trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with "Replenishing Five Herbs Decoction" (200ml per dose, twice daily, one dose per application, as per internal protocol of Nanjing Central Hospital), supplemented with Atorvastatin (produced by Pfizer, USA, national drug registration number H20051407, 10mg, one tablet daily).
Drug: Atorvastatin · Drug: Replenishing Five Herbs Decoction
The treatment consists of a placebo pill, combined with atorvastatin (produced by Pfizer, registration number H20051407, 10mg, taken once daily, one tablet). The placebo is a mixture of 10% herbal extract and rice, combined with edible seasonings, and has the same appearance, shape, smell, and specifications as the "Yang Huo Han Wu" formula.
Drug: Atorvastatin · Drug: Replenishing Five Herbs Decoction Placebo
10 mg, once daily, one tablet
Replenishing Five Herbs Decoction (200ml per dose, to be taken twice daily, once in the morning and once in the evening, according to the internal protocol of Nanjing Central Hospital).Prescription: Astragalus (60g), Red Atractylocarpus (10g), Moutan (10g), Peach Kernel (10g), Rubia cordifolia (10g), Chuanxiong (10g), and Digitalsis (10g). Prepare as a decoction, and administer the resulting liquid orally, in a 200ml dose, twice daily, in the morning and evening.
The placebo was made from a 10% mixture of ginseng, rice, and edible flavorings, and was designed to have the same appearance, shape, smell, and specifications as the "Replenishing Five Herbs Decoction."
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.
Time frame: Baseline (before intervention) and the day after completion of the 3-month treatment course
Fugl-Meyer Assessment of Motor Function Score
Motor function assessed with the Fugl-Meyer Assessment; scored independently by physicians before the intervention and by a separate group of physicians after the intervention.
Time frame: Baseline and the end of the 3-month intervention
Modified Barthel Index Score
Activities of daily living and self-care ability assessed with the Modified Barthel Index (score range 0-100).
Time frame: Baseline and the end of the 3-month intervention
Montreal Cognitive Assessment Score
Cognitive function assessed with the Montreal Cognitive Assessment.
Time frame: Baseline and the end of the 3-month intervention
National Institutes of Health Stroke Scale Score
Neurological deficit assessed with the NIHSS (score range 0-42). Pre-specified clinical efficacy categories are defined by the percentage change in score: excellent, a decrease of 50% or more; good, a decrease of 30% or more; fair, a decrease of 20% or more; poor, not meeting these criteria.
Time frame: Baseline and the end of the 3-month intervention
Incidence of New Intracerebral Hemorrhage
Events identified by telephone follow-up every two weeks and confirmed by medical records and imaging.
Time frame: From randomization to the end of the 3-year telephone follow-up
Incidence of Recurrent or New Cerebral Infarction
Events identified by telephone follow-up every two weeks and confirmed by medical records and imaging.
Time frame: From randomization to the end of the 3-year telephone follow-up
All-Cause Mortality
Events identified by telephone follow-up every two weeks and confirmed by medical records and imaging.
Time frame: From randomization to the end of the 3-year telephone follow-up
Incidence of Adverse Events and Serious Adverse Events
Assessed at each visit and by telephone follow-up every two weeks; recorded in the safety follow-up log with time of onset, severity, management, relationship to the study drug, and outcome.
Time frame: From first dose to the end of the study (including the 3-year telephone follow-up)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital with Nanjing Medical University →