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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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.