Back to resultsEffectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
Primary Purpose
Stroke, Acute Ischemic Stroke
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Angongniuhuang Pill
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Angongniuhuang Pill, consciousness level of patients who suffered from a stroke
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.
Sites / Locations
- Zhongshan Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Glasgow Coma Scale (GCS) within 90 days after stroke onset.
Secondary Outcome Measures
The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.
Global disability on modified Rankin scale at 90 days.
NIH stroke scale
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00817609
Brief Title
Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic Stroke
Keywords
Angongniuhuang Pill, consciousness level of patients who suffered from a stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Angongniuhuang Pill
Intervention Description
7 days of Angongniuhuang Pill
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
7 days of placebo
Primary Outcome Measure Information:
Title
Glasgow Coma Scale (GCS) within 90 days after stroke onset.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.
Time Frame
90 days
Title
Global disability on modified Rankin scale at 90 days.
Time Frame
90 days
Title
NIH stroke scale
Time Frame
90 days
Title
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
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dingfang Cai, MD
Email
doctorcn@hotmail.com
Facility Information:
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingfang Cai, MD
Email
doctorcn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhan Sun, MD
First Name & Middle Initial & Last Name & Degree
Wenwei Li, MD
First Name & Middle Initial & Last Name & Degree
Junpeng Gao, MD, PhD
First Name & Middle Initial & Last Name & Degree
Chenling Yao, MD
First Name & Middle Initial & Last Name & Degree
Zhenju Song, MD
First Name & Middle Initial & Last Name & Degree
Chaoyang Tong, MD
First Name & Middle Initial & Last Name & Degree
Yuping Tang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Chunfei Jiang, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16009770
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.
Results Reference
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Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
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