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NCT Number: NCT07250035

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

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.

Treatment and study plan

Jiedu Huayu Oral Prescription

Drug

Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy

Placebo

Drug

A placebo similar to the Jiedu Huayu Oral Prescription

Primary outcomes

  1. Vascular events

    Time frame: 180 days after onset

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

Secondary outcomes

  1. Incidence of Vascular Events at 30 Days

    Time frame: 30 days after onset

    Incidence of vascular events.

  2. Incidence of Vascular Events at 90 Days

    Time frame: 90 days after onset

    Incidence of vascular events.

  3. Incidence of Vascular Events at 1 Year

    Time frame: 1 year after onset

    Incidence of vascular events.

  4. Changes in Neurocognitive Function

    Time frame: 180 days after onset

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

  5. Neurological Function Recovery at 30 Days

    Time frame: 30 days after onset

    Neurological function recovery evaluated by mRS score.

  6. Neurological Function Recovery at 90 Days

    Time frame: 90 days after onset

    Neurological function recovery evaluated by mRS score.

  7. Neurological Function Recovery at 180 Days

    Time frame: 180 days after onset

    Neurological function recovery evaluated by mRS score.

  8. Neurological Function Recovery at 1 Year

    Time frame: 1 year after onset

    Neurological function recovery evaluated by mRS score.

  9. Changes in Quality of Life at 30 Days

    Time frame: 30 days after onset

    Changes in quality of life assessed by SF-36 and EQ-5D scales.

  10. Changes in Quality of Life at 90 Days

    Time frame: 90 days after onset

    Changes in quality of life assessed by SF-36 and EQ-5D scales.

  11. Changes in Quality of Life at 180 Days

    Time frame: 180 days after onset

    Changes in quality of life assessed by SF-36 and EQ-5D scales.

  12. Changes in Quality of Life at 1 Year

    Time frame: 1 year after discharge

    Changes in quality of life assessed by SF-36 and EQ-5D scales.

Other outcomes

  1. Safety Indicators at 7 Days

    Time frame: 7 days after onset

    Hematoma expansion rate in safety indicators (defined as a 33% increase in hematoma volume or an absolute increase of 6ml compared with the baseline CT hematoma volume).

  2. Safety Indicators at 14 Days

    Time frame: 14 days after onset

    Hematoma expansion rate in safety indicators (using the same evaluation standard as that at 7 days after onset).

  3. Safety Indicators during medication

    Time frame: During medication

    Incidence of newly developed severe liver and kidney function abnormalities in safety indicators.

  4. Safety Indicators during entire study period

    Time frame: Entire study period

    Incidence of non-vascular death, adverse events/serious adverse events reported by researchers.

Study contacts

Contact information is provided by the study sponsor or research team.

Dandan Wang Wang

CONTACT

[email protected]

+8615053772817

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Baofeng County People's Hospital
  • Dongzhimen Hospital, Beijing
  • Guantao County People's Hospital
  • Huairou Hospital of Traditional Chinese Medicine
  • Jiyuan Hospital of Traditional Chinese Medicine
  • Luohe Central Hospital
  • Lushan County Hospital of Traditional Chinese Medicine
  • Nanyang First People's Hospital of Henan province
  • Qingdao Huangdao District Central Hospital
  • Taoyuan County People's Hospital
  • The First Hospital of Jilin University
  • Tonghua People's Hospital
  • Weihai Wendeng District Central Hospital
  • Wuyuan County People's Hospital
  • Xianghe County Hospital of Traditional Chinese Medicine
  • Yutian County Hospital of Traditional Chinese Medicine

Registry information

Official study 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

Acronym: CHN-CAA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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