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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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ClinicalTrials.gov Identifier: NCT00817609
Recruitment Status : Unknown
Verified September 2009 by Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : January 6, 2009
Last Update Posted : May 28, 2010
Sponsor:
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Stroke Acute Ischemic Stroke Drug: Angongniuhuang Pill Drug: placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Arm Intervention/treatment
Experimental: A Drug: Angongniuhuang Pill
7 days of Angongniuhuang Pill
Placebo Comparator: B Drug: placebo
7 days of placebo



Primary Outcome Measures :
  1. Glasgow Coma Scale (GCS) within 90 days after stroke onset. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Global disability on modified Rankin scale at 90 days. [ Time Frame: 90 days ]
  3. NIH stroke scale [ Time Frame: 90 days ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817609


Contacts
Contact: Dingfang Cai, MD doctorcn@hotmail.com

Locations
China, Shanghai
Zhongshan Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Dingfang Cai, MD       doctorcn@hotmail.com   
Principal Investigator: Zhan Sun, MD         
Sub-Investigator: Wenwei Li, MD         
Sub-Investigator: Junpeng Gao, MD, PhD         
Sub-Investigator: Chenling Yao, MD         
Sub-Investigator: Zhenju Song, MD         
Sub-Investigator: Chaoyang Tong, MD         
Sub-Investigator: Yuping Tang, MD, PhD         
Sub-Investigator: Chunfei Jiang, MD         
Sponsors and Collaborators
Fudan University

Publications:
Responsible Party: Office for Traditional Chinese medicine, Shanghai Municipal Health Bureau
ClinicalTrials.gov Identifier: NCT00817609     History of Changes
Other Study ID Numbers: 2008L060A
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: September 2009

Keywords provided by Fudan University:
Angongniuhuang Pill
consciousness level of patients who suffered from a stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases