Status:
COMPLETED
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capi...
Detailed Description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multicenter trial. Patients who met the inclusion and exclusion criteria will be randomized 1:1 into two groups af...
Eligibility Criteria
Inclusion
- Male or female participates aged 40-80 years.
- Diagnosis with acute ischemic stroke.
- Diagnosis with acute cerebral infarctions of internal carotid artery system.
- 10≤ Baseline NIHSS \<20.
- Time of onset ≤36h.
- Provision of informed consent.
Exclusion
- Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor.
- Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- Patients with hemorrhagic transformation after cerebral infarction.
- Received or planned to receive endovascular treatment, including thrombectomy, ultra early thrombectomy and stenting.
- Received or planned to receive decompression craniectomy.
- With mRS score \>1 before onset of this episode.
- Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia.
- With thrombocytopenia (\<100 x10\^9/L), hematologic diseases or other systemic bleeding tendency.
- With Alanine transaminase or Aspartate aminotransferase \>1.5 times than normal upper limit or Creatinine \>1.5 times than normal upper limit.
- Allergic to ingredients of AngongNiuhuang pill.
- Received AngongNiuhuang pill within 1 month.
- Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation.
- Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails.
- Participates with a life expectancy less than 3 months.
- Incapable to follow this study due to mental illness, cognitive or emotional disorders.
- Participates are not eligible for this clinical trial as evaluated by the investigators.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04475328
Start Date
October 1 2020
End Date
July 30 2022
Last Update
September 11 2023
Active Locations (1)
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1
Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing
Beijing, Beijing Municipality, China, 100730