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

NCT ID: NCT00817609

Last Updated: 2010-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Acute Ischemic Stroke

Keywords

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Angongniuhuang Pill consciousness level of patients who suffered from a stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Angongniuhuang Pill

Intervention Type DRUG

7 days of Angongniuhuang Pill

B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

7 days of placebo

Interventions

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Angongniuhuang Pill

7 days of Angongniuhuang Pill

Intervention Type DRUG

placebo

7 days of placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Municipal Health Bureau

Locations

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Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Dingfang Cai, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Dingfang Cai, MD

Role: primary

References

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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. doi: 10.1001/archneur.62.7.1126.

Reference Type BACKGROUND
PMID: 16009770 (View on PubMed)

Other Identifiers

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2008L060A

Identifier Type: -

Identifier Source: org_study_id