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

May 26, 2010 updated by: Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: rhubarb
14 days of rhubarb
Placebo Comparator: B
Drug: Placebo
14 days of Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
NIH stroke scale
Time Frame: 90 days
90 days
Barthel Index
Time Frame: 90 days
90 days
Global disability on modified Rankin scale at 90 days
Time Frame: 90 days
90 days
Death rate
Time Frame: 90 days
90 days
Syndrome score by Traditional Chinese Medicine (TCM) standard
Time Frame: 90 days
90 days
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,
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Study Registration Dates

First Submitted

December 29, 2008

First Submitted That Met QC Criteria

December 29, 2008

First Posted (Estimate)

December 30, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rhubarb cerebral hemorrhage

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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