Stroke Clinical Trial
NCT number | NCT00817609 |
Other study ID # | 2008L060A |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 2/Phase 3 |
First received | January 5, 2009 |
Last updated | May 26, 2010 |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glasgow Coma Scale (GCS) within 90 days after stroke onset. | 90 days | No | |
Secondary | 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 | No | |
Secondary | Global disability on modified Rankin scale at 90 days. | 90 days | No | |
Secondary | NIH stroke scale | 90 days | No | |
Secondary | 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 | Yes |
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