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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
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00817609
First received: January 5, 2009
Last updated: May 26, 2010
Last verified: September 2009
History of Changes
  Purpose

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
Stroke
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:

MedlinePlus related topics: Coma
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Office for Traditional Chinese medicine, Shanghai Municipal Health Bureau
ClinicalTrials.gov 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:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
 Brain Ischemia
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013