Moyamoya DiseaseEarly Phase 1NCT07906652
Clinical Evaluation of the Safety and Efficacy of "Buyan Huan Wu Tang" Combined With Atorvastatin in the Treatment of Atypical Pneumonia
A Early Phase 1 study testing Atorvastatin and Replenishing Five Herbs Decoction in people with Moyamoya Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Atorvastatin and Replenishing Five Herbs Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 chronic obstructive pulmonary disease (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.
- 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.
- The patient's basic condition has remained stable for the past month, and no additional medications are required.
- Able to understand and agree to comply with the testing requirements and limitations.
Who cannot join
- 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 HIV, syphilis, or hepatitis B/C.
- 4. Currently participating in other drug clinical trials. 5. History of intolerance or allergy to any component of the investigational 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangsu Province Hospital (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210029
About this study
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.
Read more
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."
- Conditions
- Moyamoya Disease
- Being tested
- Atorvastatin, Replenishing Five Herbs Decoction, Replenishing Five Herbs Decoction Placebo
- Keywords
- Moyomoya Disease, traditional Chinese medicine, cerebral perfusion, Replenishing Five Herbs Decoction, Atypical cases of Moyomoya Disease
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
10 mg, once daily, one tablet
Replenishing Five Herbs DecoctionDrug
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.
Replenishing Five Herbs Decoction PlaceboDrug
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."
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin + Replenishing Five Herbs Decoction | Experimental | 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). Receives: Drug: Atorvastatin; Drug: Replenishing Five Herbs Decoction |
| Atorvastatin + Replenishing Five Herbs Decoction Placebo | Placebo comparator | 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. Receives: Drug: Atorvastatin; Drug: Replenishing Five Herbs Decoction Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before intervention) and the day after completion of the 3-month treatment course
Secondary outcomes (7)
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.
Measured: 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).
Measured: Baseline and the end of the 3-month intervention
Montreal Cognitive Assessment Score
Cognitive function assessed with the Montreal Cognitive Assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization to the end of the 3-year telephone follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start31 Dec 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906652
- Sponsor's protocol ID
- 2026-SR-030
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of "Buyan Huan Wu Tang" Combined With Atorvastatin in the Treatment of Atypical Pneumonia
- ClinicalTrials.gov ID
- NCT07906652
- Acronym / sponsor ID
- 2026-SR-030
- Conditions
- Moyamoya Disease
- Keywords
- Moyomoya Disease, traditional Chinese medicine, cerebral perfusion, Replenishing Five Herbs Decoction, Atypical cases of Moyomoya Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin + Replenishing Five Herbs Decoction | Experimental | Drug: Atorvastatin, Drug: Replenishing Five Herbs DecoctionTreatment 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). |
| Atorvastatin + Replenishing Five Herbs Decoction Placebo | Placebo comparator | Drug: Atorvastatin, Drug: Replenishing Five Herbs Decoction PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 chronic obstructive pulmonary disease (8B22.B) and stroke (A07.01.01).
Key exclusion criteria (5 listed)
- 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 HIV, syphilis, or hepatitis B/C.
- 4. Currently participating in other drug clinical trials. 5. History of intolerance or allergy to any component of the investigational 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin10 mg, once daily, one tablet | Drug | Atorvastatin + Replenishing Five Herbs Decoction, Atorvastatin + Replenishing Five Herbs Decoction Placebo |
| Replenishing Five Herbs DecoctionReplenishing 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. | Drug | Atorvastatin + Replenishing Five Herbs Decoction |
| Replenishing Five Herbs Decoction PlaceboThe 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." | Drug | Atorvastatin + Replenishing Five Herbs Decoction Placebo |
Primary outcome
Percentage of Participants With an Increase of at Least 1 Point in Cerebral Perfusion Staging Score
Time frame: Baseline (before intervention) and the day after completion of the 3-month treatment course
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.
7 secondary outcomes
Fugl-Meyer Assessment of Motor Function Score
Time frame: Baseline and the end of the 3-month intervention
Modified Barthel Index Score
Time frame: Baseline and the end of the 3-month intervention
Montreal Cognitive Assessment Score
Time frame: Baseline and the end of the 3-month intervention
National Institutes of Health Stroke Scale Score
Time frame: Baseline and the end of the 3-month intervention
Incidence of New Intracerebral Hemorrhage
Time frame: From randomization to the end of the 3-year telephone follow-up
Incidence of Recurrent or New Cerebral Infarction
Time frame: From randomization to the end of the 3-year telephone follow-up
All-Cause Mortality
Time frame: From randomization to the end of the 3-year telephone follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Atorvastatin and Replenishing Five Herbs Decoction in people with Moyamoya Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With an Increase of at Least 1 Point in Cerebral Perfusion Staging Score (time frame: Baseline (before intervention) and the day after completion of the 3-month treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.