Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy (CHN-CAA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Amyloid Angiopathy
• Intervention / Treatment: Drug: Placebo; Drug: Jiedu Huayu Oral Prescription

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 Type: Interventional
• Enrollment (Estimated): 436
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dandan Wang Wang; Phone Number: +8615053772817; Email: shuxianlyu@163.com

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ① Possible or very likely CAA-ICH;

  • Within 7 days of onset; ③ Primary supratentorial intracerebral hemorrhage (bleeding volume ≤30ml);

    • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Drug: Jiedu Huayu Oral Prescription; Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy
Placebo Comparator: Placebo Comparator	Drug: Placebo; A placebo similar to the Jiedu Huayu Oral Prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular events	Incidence of vascular events, including hemorrhagic and ischemic vascular events.	180 days after onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Vascular Events at 30 Days	Incidence of vascular events.	30 days after onset
Incidence of Vascular Events at 90 Days	Incidence of vascular events.	90 days after onset
Incidence of Vascular Events at 1 Year	Incidence of vascular events.	1 year after onset
Changes in Neurocognitive Function	Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.	180 days after onset
Neurological Function Recovery at 30 Days	Neurological function recovery evaluated by mRS score.	30 days after onset
Neurological Function Recovery at 90 Days	Neurological function recovery evaluated by mRS score.	90 days after onset
Neurological Function Recovery at 180 Days	Neurological function recovery evaluated by mRS score.	180 days after onset
Neurological Function Recovery at 1 Year	Neurological function recovery evaluated by mRS score.	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.	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.	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.	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.	1 year after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Indicators at 7 Days	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).	7 days after onset
Safety Indicators at 14 Days	Hematoma expansion rate in safety indicators (using the same evaluation standard as that at 7 days after onset).	14 days after onset
Safety Indicators during medication	Incidence of newly developed severe liver and kidney function abnormalities in safety indicators.	During medication
Safety Indicators during entire study period	Incidence of non-vascular death, adverse events/serious adverse events reported by researchers.	Entire study period

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: The First Hospital of Jilin University; Dongzhimen Hospital, Beijing; Huairou Hospital of Traditional Chinese Medicine; Luohe Central Hospital; Weihai Wendeng District Central Hospital; Nanyang First People's Hospital of Henan province; 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 record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Proteostasis Deficiencies; Intracranial Arterial Diseases; Cerebral Arterial Diseases; Amyloidosis; Nutritional and Metabolic Diseases; Cerebral Amyloid Angiopathy
• Other Study ID Numbers: 2024ZD0522204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No