Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke

Study Overview
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Brief Summary
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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.

Conditions
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Stroke, Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Angongniuhuang Pill
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Angongniuhuang Pill<br>* 7 days of Angongniuhuang Pill<br>|
| Placebo Comparator: B<br> | Drug: placebo<br>* 7 days of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Scale (GCS) within 90 days after stroke onset. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angongniuhuang Pill, consciousness level of patients who suffered from a stroke