Cerebral Amyloid AngiopathyPhase 3CHN-CAANCT07250035
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
A Phase 3 study testing Jiedu Huayu Oral Prescription in people with Cerebral Amyloid Angiopathy, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cerebral Amyloid Angiopathy
- What is being tested?
- Jiedu Huayu Oral Prescription
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 30 Nov 2028
- Phase
- Phase 3
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Possible or very likely CAA-ICH;
- Within 7 days of onset; ③ Primary supratentorial intracerebral hemorrhage (bleeding volume ≤40ml);
- GCS≥8 points;
- NIHSS score ≤25 points; ⑥50≤age≤90 years old; ⑦ Gender is not limited; ⑧ The subject or their legal representative gives informed consent and signs the informed consent form.
Who cannot join
- Those who are known to be allergic to the components of the traditional Chinese medicine compound used in the experiment;
- It is known that after treatment with vascular malformations, aneurysms, coagulation disorders, anticoagulant or antiplatelet drugs, Intracranial conditions caused by clear etiologies such as thrombolytic therapy, post-infarction hemorrhage transformation, hematological diseases, moyamoya disease, etc;
- Patients with traumatic intracranial hemorrhage;
- Patients with active peptic ulcers or other clear tendencies of rebleeding;
- Patients with severe liver or kidney dysfunction (Note: Severe liver dysfunction is defined as ALT or AST being greater than.
- ⑥ Those who have received or are planning to undergo surgical treatment;
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- ⑦ Those who suffer from other life-threatening serious diseases and have an expected survival time of less than six months;
- ⑧ Other conditions that significantly limit the evaluation of neurological function, prevent the completion of cranial magnetic resonance imaging, or affect the follow-up of patient;
- ⑨ Pregnant women, those planning to become pregnant or lactating women;
- ⑩Those who are currently participating in other interventional clinical trials.
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, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Dr., 010-5997-5835, shuxianlyu@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients.
Read the detailed description
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients. It is expected that this will be systematically evaluated through a multi-center, randomized, double-blind, mimic-controlled clinical trial.The effectiveness and safety of the protocol in reducing the incidence of vascular events were observed, and its impact on patients' cognitive function and neurological function was also examined. The research plan includes patients with CAA-related intracranial hemorrhage within 7 days of onset.The therapeutic effect was measured by indicators such as the proportion of vascular events in patients at different stages of the disease, including hematoma expansion rate and abnormal liver and kidney functions.The safety was evaluated based on the incidence rate, and the anti-inflammatory, antioxidant and other properties of traditional Chinese medicine prescriptions were explored with the aid of imaging and biological indicators.The mechanism for improving cerebrovascular function. It is expected that through this study, it will provide clinical treatment for patients with CAA-related intracranial hemorrhage.A brand-new and effective plan brings better prognosis to patients, reduces the medical burden on patients' families and lowers the social burden medical costs. At the same time, it will also provide important reference basis for subsequent related research and promote the integrated treatment of traditional Chinese and Western medicine.
- Conditions
- Cerebral Amyloid Angiopathy
- Being tested
- Jiedu Huayu Oral Prescription, Placebo
- Medical subject headings
- Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiedu Huayu Oral PrescriptionDrug
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy
PlaceboDrug
A placebo similar to the Jiedu Huayu Oral Prescription
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
| Experimental | Experimental | Not described Receives: Drug: Jiedu Huayu Oral Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular events
Incidence of vascular events, including hemorrhagic and ischemic vascular events.
Measured: 180 days after onset
Secondary outcomes (12)
Incidence of Vascular Events at 30 Days
Incidence of vascular events.
Measured: 30 days after onset
Incidence of Vascular Events at 90 Days
Incidence of vascular events.
Measured: 90 days after onset
Incidence of Vascular Events at 1 Year
Incidence of vascular events.
Measured: 1 year after onset
Changes in Neurocognitive Function
Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.
Measured: 180 days after onset
Neurological Function Recovery at 30 Days
Neurological function recovery evaluated by mRS score.
Measured: 30 days after onset
Neurological Function Recovery at 90 Days
Neurological function recovery evaluated by mRS score.
Measured: 90 days after onset
Neurological Function Recovery at 180 Days
Neurological function recovery evaluated by mRS score.
Measured: 180 days after onset
Neurological Function Recovery at 1 Year
Neurological function recovery evaluated by mRS score.
Measured: 1 year after onset
Changes in Quality of Life at 30 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Measured: 30 days after onset
Changes in Quality of Life at 90 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Measured: 90 days after onset
Changes in Quality of Life at 180 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Measured: 180 days after onset
Changes in Quality of Life at 1 Year
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Measured: 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start30 Jan 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, The First Hospital of Jilin University, Huairou Hospital of Traditional Chinese Medicine, Weihai Wendeng District Central Hospital, Nanyang First People's Hospital of Henan province, Luohe Central Hospital, Baofeng County People's Hospital, Taoyuan County People's Hospital, Qingdao Huangdao District Central Hospital, Guantao County People's Hospital, Lushan County Hospital of Traditional Chinese Medicine, Yutian County Hospital of Traditional Chinese Medicine, Xianghe County Hospital of Traditional Chinese Medicine, Wuyuan County People's Hospital, Jiyuan Hospital of Traditional Chinese Medicine, Tonghua People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250035
- Sponsor's protocol ID
- 2024ZD0522204
- Acronym
- CHN-CAA
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2025
- Last updated
- 30 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
- ClinicalTrials.gov ID
- NCT07250035
- Acronym / sponsor ID
- CHN-CAA / 2024ZD0522204
- Conditions
- Cerebral Amyloid Angiopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, The First Hospital of Jilin University, Huairou Hospital of Traditional Chinese Medicine, Weihai Wendeng District Central Hospital, Nanyang First People's Hospital of Henan province, Luohe Central Hospital, Baofeng County People's Hospital, Taoyuan County People's Hospital, Qingdao Huangdao District Central Hospital, Guantao County People's Hospital, Lushan County Hospital of Traditional Chinese Medicine, Yutian County Hospital of Traditional Chinese Medicine, Xianghe County Hospital of Traditional Chinese Medicine, Wuyuan County People's Hospital, Jiyuan Hospital of Traditional Chinese Medicine, Tonghua People's Hospital
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 25 Nov 2025 (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.
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients.
Detailed description
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients. It is expected that this will be systematically evaluated through a multi-center, randomized, double-blind, mimic-controlled clinical trial.The effectiveness and safety of the protocol in reducing the incidence of vascular events were observed, and its impact on patients' cognitive function and neurological function was also examined. The research plan includes patients with CAA-related intracranial hemorrhage within 7 days of onset.The therapeutic effect was measured by indicators such as the proportion of vascular events in patients at different stages of the disease, including hematoma expansion rate and abnormal liver and kidney functions.The safety was evaluated based on the incidence rate, and the anti-inflammatory, antioxidant and other properties of traditional Chinese medicine prescriptions were explored with the aid of imaging and biological indicators.The mechanism for improving cerebrovascular function. It is expected that through this study, it will provide clinical treatment for patients with CAA-related intracranial hemorrhage.A brand-new and effective plan brings better prognosis to patients, reduces the medical burden on patients' families and lowers the social burden medical costs. At the same time, it will also provide important reference basis for subsequent related research and promote the integrated treatment of traditional Chinese and Western medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: Placebo |
| Experimental | Experimental | Drug: Jiedu Huayu Oral Prescription |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ① Possible or very likely CAA-ICH;
Key exclusion criteria (10 listed)
- Those who are known to be allergic to the components of the traditional Chinese medicine compound used in the experiment;
- ⑥ Those who have received or are planning to undergo surgical treatment;
- ⑦ Those who suffer from other life-threatening serious diseases and have an expected survival time of less than six months;
- ⑧ Other conditions that significantly limit the evaluation of neurological function, prevent the completion of cranial magnetic resonance imaging, or affect the follow-up of patient;
- ⑨ Pregnant women, those planning to become pregnant or lactating women;
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 |
|---|---|---|
| Jiedu Huayu Oral PrescriptionJiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy | Drug | Experimental |
| PlaceboA placebo similar to the Jiedu Huayu Oral Prescription | Drug | Placebo Comparator |
Primary outcome
Vascular events
Time frame: 180 days after onset
Incidence of vascular events, including hemorrhagic and ischemic vascular events.
12 secondary outcomes
Incidence of Vascular Events at 30 Days
Time frame: 30 days after onset
Incidence of Vascular Events at 90 Days
Time frame: 90 days after onset
Incidence of Vascular Events at 1 Year
Time frame: 1 year after onset
Changes in Neurocognitive Function
Time frame: 180 days after onset
Neurological Function Recovery at 30 Days
Time frame: 30 days after onset
Neurological Function Recovery at 90 Days
Time frame: 90 days after onset
Neurological Function Recovery at 180 Days
Time frame: 180 days after onset
Neurological Function Recovery at 1 Year
Time frame: 1 year after onset
Changes in Quality of Life at 30 Days
Time frame: 30 days after onset
Changes in Quality of Life at 90 Days
Time frame: 90 days after onset
Changes in Quality of Life at 180 Days
Time frame: 180 days after onset
Changes in Quality of Life at 1 Year
Time frame: 1 year after discharge
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 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jiedu Huayu Oral Prescription in people with Cerebral Amyloid Angiopathy, run by Beijing Tiantan Hospital 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Dandan Wang Wang (+8615053772817, shuxianlyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular events (time frame: 180 days after onset). 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 Sep 2026.