Effectiveness and Safety of Rhubarb for the Treatment of... | NCT00815737

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

NCT00815737

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

May 28, 2010Estimated

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

Lung Infection
Cerebral Hemorrhage
Pneumonia

Interventions

rhubarb
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 29, 2008

First Submission Date that Met QC Criteria

Dec 29, 2008

First Posted Date

Dec 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2010

Last Update Posted Date

May 28, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
A	Experimental		Drug: rhubarb
B	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
rhubarb	Drug	14 days of rhubarb	A
Placebo

Measure	Description	Time Frame
The lung infection rate within 14 days after stroke onset		14 days

Measure	Description	Time Frame
Global disability on modified Rankin scale at 90 days		90 days
NIH stroke scale		90 days
Barthel Index

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan hospital of Fudan University		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15719749	Background	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.

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D002543	Cerebral Hemorrhage
D011014	Pneumonia