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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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

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.

Dandan Wang Wang contact

+8615053772817

shuxianlyu@163.com

China1 site, 1 recruiting
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070

    Dr., 010-5997-5835, shuxianlyu@163.com

    Recruiting

Other trials in China

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.

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 groups in NCT07250035
Study groupRoleWhat they receive
Placebo ComparatorPlacebo comparatorNot described
Receives: Drug: Placebo
ExperimentalExperimentalNot described
Receives: Drug: Jiedu Huayu Oral Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular events

    Incidence of vascular events, including hemorrhagic and ischemic vascular events.

    Measured: 180 days after onset

Secondary outcomes (12)
  1. Incidence of Vascular Events at 30 Days

    Incidence of vascular events.

    Measured: 30 days after onset

  2. Incidence of Vascular Events at 90 Days

    Incidence of vascular events.

    Measured: 90 days after onset

  3. Incidence of Vascular Events at 1 Year

    Incidence of vascular events.

    Measured: 1 year after onset

  4. Changes in Neurocognitive Function

    Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.

    Measured: 180 days after onset

  5. Neurological Function Recovery at 30 Days

    Neurological function recovery evaluated by mRS score.

    Measured: 30 days after onset

  6. Neurological Function Recovery at 90 Days

    Neurological function recovery evaluated by mRS score.

    Measured: 90 days after onset

  7. Neurological Function Recovery at 180 Days

    Neurological function recovery evaluated by mRS score.

    Measured: 180 days after onset

  8. Neurological Function Recovery at 1 Year

    Neurological function recovery evaluated by mRS score.

    Measured: 1 year after onset

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted25 Nov 2025
  2. Study start30 Jan 2026
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

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)
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

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