Clinical trial NCT03733002: Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.
Official title: Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
AngongNiuhuang pill
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Cangzhou Central Hospital
name: The Second Hospital of Hebei Medical University
name: Affiliated Hospital of Chengde Medical University
First posted: 2018-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase.

Detailed description: This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 100 patients (18 years ≤age ≤80 years) within 24 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 5-20 points. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.The primary purpose of this trial was to evaluate the effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase. The study consists of five visits including the day of randomization, 2-6 days, monitor daily temperature, 7 days when the therapy is done, 30 days, and 90 days when the follow-up is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The improvement of life function will be assessed by Modified Rankin Scale(namely score=0-2). The trial is anticipated to last from July 2018 to December 2019 with 100 subjects recruited form 5 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese GCP standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.

Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke.
2. 18 years ≤ age ≤ 80 years.
3. Within 24 hours from symptom onset.
4. Baseline NIHSS range 5 from 20.
5. Provision of informed consent.

Exclusion Criteria:

1. Not suitable for taking this medicine after dialectic of traditional Chinese medical doctor.
2. Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
3. Receive thrombolysis or endovascular treatment.
4. mRS\>1 at randomization (pre-morbid historical assessment).
5. Thrombocytopenia(\<100×10\*9/L) , hematologic diseases and other systemic bleeding tendency.
6. Sleepy head (GCS≤7).
7. Alanine transaminase \> 1.5 times normal upper limit or Aspartate aminotransferase \> 1.5 times normal upper limit.
8. Glomerular filtration rate\<60 ml/min/1.73m2.
9. Patients who have been taking AngongNiuhuang pills within 3 months.
10. Pregnancy or lactation, women in childbearing age with negative pregnancy test refuse to accept contraception.
11. Participate in clinical studies of other research drugs within the last 30 days.
12. Patients with a life expectancy of less than three months.
13. Incapable to follow this study for mental illness, cognitive or emotional disorders.
14. Unsuitable for this study in the opinion of the investigators.

Primary outcomes:
measure: The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
timeFrame: 90days
measure: Severity Adverse Event
timeFrame: 90days
Secondary outcomes:
measure: The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)
timeFrame: 7days, 30days
measure: Neurological recovery
timeFrame: 7 days, 30 days,90 days
measure: Barthel Index
timeFrame: 30 days, 90 days
measure: Recurrent stroke, death and other vascular events
timeFrame: 30 days, 90 days
measure: Changes of biomarker (hs-CRP)
timeFrame: 7 days
measure: Changes of biomarker (IL-10)
timeFrame: 7days
measure: Changes of biomarker (TNF-α)
timeFrame: 7days
measure: Adverse Events
timeFrame: 7 days, 90 days
measure: Severity Adverse Event
timeFrame: 7days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bin Peng
state: Beijing
Study officials:
affiliation: Peking Union Medical College
name: Bin Peng, MD
role: PRINCIPAL_INVESTIGATOR
References: