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

NCT07250035 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2024ZD0522204
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Amyloid Angiopathy

Outcome Measures

Primary Outcomes (1)

• Vascular events

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

  180 days after onset

Secondary Outcomes (12)

• Incidence of Vascular Events at 30 Days

  30 days after onset

• Incidence of Vascular Events at 90 Days

  90 days after onset

• Incidence of Vascular Events at 1 Year

  1 year after onset

• Changes in Neurocognitive Function

  180 days after onset

• Neurological Function Recovery at 30 Days

  30 days after onset

Other Outcomes (4)

• Safety Indicators at 7 Days

  7 days after onset

• Safety Indicators at 14 Days

  14 days after onset

• Safety Indicators during medication

  During medication

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Experimental

EXPERIMENTAL

Drug: Jiedu Huayu Oral Prescription

Interventions

Placebo DRUG

A placebo similar to the Jiedu Huayu Oral Prescription

Placebo Comparator

Jiedu Huayu Oral Prescription DRUG

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

Experimental

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Dandan Wang Wang

CONTACT

+8615053772817; shuxianlyu@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: November 25, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)