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

Stroke Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00817609
• Other study ID #: 2008L060A
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: January 5, 2009
• Last updated: May 26, 2010

Study information

• Verified date: September 2009
• Source: Fudan University
• Contact: Dingfang Cai, MD
• Email: doctorcn[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Drug:
• Angongniuhuang Pill
7 days of Angongniuhuang Pill
• placebo
7 days of placebo

Locations

Country	Name	City	State
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Coma Scale (GCS) within 90 days after stroke onset.		90 days	No
Secondary	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	No
Secondary	Global disability on modified Rankin scale at 90 days.		90 days	No
Secondary	NIH stroke scale		90 days	No
Secondary	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	Yes