Clinical trial NCT00817609: Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stroke
Acute Ischemic Stroke
Keywords: Angongniuhuang Pill
consciousness level of patients who suffered from a stroke
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 60
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glasgow Coma Scale (GCS) within 90 days after stroke onset.
timeFrame: 90 days
Secondary outcomes:
measure: The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.
timeFrame: 90 days
measure: Global disability on modified Rankin scale at 90 days.
timeFrame: 90 days
measure: NIH stroke scale
timeFrame: 90 days
measure: 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
timeFrame: 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: Tsao JW, Hemphill JC 3rd, Johnston SC, Smith WS, Bonovich DC. Initial Glasgow Coma Scale score predicts outcome following thrombolysis for posterior circulation stroke. Arch Neurol. 2005 Jul;62(7):1126-9. doi: 10.1001/archneur.62.7.1126.