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Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage

NCT ID: NCT00815737

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute cerebral hemorrhage. The study is designed to look at both infection rate 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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Lung Infection Cerebral Hemorrhage Pneumonia

Keywords

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Lung Infection After Cerebral Hemorrhage Prevention of Pneumonia Rhubarb

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

rhubarb

Intervention Type DRUG

14 days of rhubarb

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

14 days of Placebo

Interventions

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rhubarb

14 days of rhubarb

Intervention Type DRUG

Placebo

14 days of Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Occurrence of an acute cerebral hemorrhage (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years.
* Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC)
* Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard
* Patients or their representatives voluntarily take part in this study and signed the informed consent

Exclusion Criteria

* Cerebral infarction, transient ischemic attack(TIA)
* Subarachnoid hemorrhage
* Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases
* Clinical signs of infection on admission
* Pregnant or breast-feeding
* Allergic to rhubarb
* Preceding or ongoing antibiotic therapy within the last 24 h
* Participation in another interventional trial
* Immunosuppressant treatment within the last 30 days
* Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases
Minimum Eligible Age

18 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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TCM department, Zhongshan hospital, Fudan University

Locations

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Zhongshan hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Cai DF, Dai W, Chen YP, Wen M, Dai HL. [Effect and mechanism of rhubarb on fibrinolysis in secondary damaged central nerve system of rats with acute hemorrhagic stroke]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2005 Jan;25(1):38-41. Chinese.

Reference Type BACKGROUND
PMID: 15719749 (View on PubMed)

Other Identifiers

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rhubarb cerebral hemorrhage

Identifier Type: -

Identifier Source: org_study_id