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

Primary Purpose

Lung Infection, Cerebral Hemorrhage, Pneumonia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

rhubarb

Placebo

About this trial

This is an interventional treatment trial for Lung Infection focused on measuring Lung Infection After Cerebral Hemorrhage, Prevention of Pneumonia, Rhubarb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhongshan hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The lung infection rate within 14 days after stroke onset

Secondary Outcome Measures

Global disability on modified Rankin scale at 90 days

NIH stroke scale

Barthel Index

Death rate

Syndrome score by Traditional Chinese Medicine (TCM) standard

Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase(AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein,

Full Information

NCT ID

NCT00815737

First Posted

December 29, 2008

Last Updated

May 26, 2010

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00815737

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Infection, Cerebral Hemorrhage, Pneumonia

Keywords

Lung Infection After Cerebral Hemorrhage, Prevention of Pneumonia, Rhubarb

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

rhubarb

Intervention Description

14 days of rhubarb

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

14 days of Placebo

Primary Outcome Measure Information:

Title

The lung infection rate within 14 days after stroke onset

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Global disability on modified Rankin scale at 90 days

Time Frame

90 days

Title

NIH stroke scale

Time Frame

90 days

Title

Barthel Index

Time Frame

90 days

Title

Death rate

Time Frame

90 days

Title

Syndrome score by Traditional Chinese Medicine (TCM) standard

Time Frame

90 days

Title

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Zhongshan hospital of Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

15719749

Citation

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.

Results Reference

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

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