Acute Ischemic Stroke, Stroke
Conditions
Keywords
Angongniuhuang Pill, consciousness level of patients who suffered from a stroke
Brief summary
This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.
Interventions
7 days of Angongniuhuang Pill
DRUGplacebo
7 days of placebo
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with * A score of not higher than 12 of Glasgow Coma Scale (GCS) * Patient age of between 18 and 80 years. * Patients or their representatives voluntarily take part in this study and signed the informed consent
Exclusion criteria
* Transient Ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage * Ischemic stroke that needs rt-PA treatment * Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition. * Pregnant or breast-feeding. * Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap. * Liable to be allergic (allergic to at lease 2 foods/drugs previously exposed) * Had been participated in other clinical trials during the last 1 month prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasgow Coma Scale (GCS) within 90 days after stroke onset. | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma. | 90 days |
| Global disability on modified Rankin scale at 90 days. | 90 days |
| NIH stroke scale | 90 days |
| Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b | 14 days |
Countries
China
Contacts
Primary ContactDingfang Cai, MD
Outcome results
None listed