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

Fudan University logo

Fudan University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Stroke
Acute Ischemic Stroke

Treatments

Drug: Angongniuhuang Pill
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00817609
2008L060A

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

A
Experimental group
Treatment:
Drug: Angongniuhuang Pill
B
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

1

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Central trial contact

Dingfang Cai, MD

Data sourced from clinicaltrials.gov

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