Jiedu Huayu oral medicine for brain hemorrhage due to cerebral amyloid angiopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study is a multicenter, randomized, double-blind, mimic-controlled phase 3 trial evaluating the safety and effectiveness of Jiedu Huayu oral prescription plus standard care versus placebo in adults with CAA-related intracerebral hemorrhage within 7 days of onset. Participants are randomized to receive either the active treatment or a matched placebo for a defined period, with ongoing monitoring for vascular events, hematoma dynamics, and safety. Outcomes include the rate of vascular events, hematoma expansion, liver and kidney function, and measures of cognitive and neurological function. The trial aims to determine whether this integrative protocol can reduce recurrent events and improve neurological outcomes in this high-risk population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Dandan Wang Wang
• Email: shuxianlyu@163.com
• Phone: +8615053772817

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.