Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedMay 28, 2010
September 1, 2009
January 5, 2009
May 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glasgow Coma Scale (GCS) within 90 days after stroke onset.
90 days
Secondary Outcomes (4)
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
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
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.
PMID: 16009770BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Last Updated
May 28, 2010
Record last verified: 2009-09