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Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Fudan University.
Recruitment status was  Not yet recruiting
Information provided by:
Fudan University Identifier:
First received: January 5, 2009
Last updated: May 26, 2010
Last verified: September 2009

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 Intervention Phase
Acute Ischemic Stroke
Drug: Angongniuhuang Pill
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Glasgow Coma Scale (GCS) within 90 days after stroke onset. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Global disability on modified Rankin scale at 90 days. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • NIH stroke scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Arms Assigned Interventions
Experimental: A Drug: Angongniuhuang Pill
7 days of Angongniuhuang Pill
Placebo Comparator: B Drug: placebo
7 days of placebo


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00817609

Contact: Dingfang Cai, MD

China, Shanghai
Zhongshan Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Dingfang Cai, MD   
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
  More Information

Responsible Party: Office for Traditional Chinese medicine, Shanghai Municipal Health Bureau Identifier: NCT00817609     History of Changes
Other Study ID Numbers: 2008L060A
Study First Received: January 5, 2009
Last Updated: May 26, 2010
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on November 25, 2014