Overview

This trial is active, not recruiting.

Conditions lung infection, cerebral hemorrhage, pneumonia
Treatments rhubarb, placebo
Phase phase 2/phase 3
Sponsor Fudan University
Start date January 2009
Trial size 100 participants
Trial identifier NCT00815737, rhubarb cerebral hemorrhage

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
rhubarb
14 days of rhubarb
(Placebo Comparator)
placebo
14 days of Placebo

Primary Outcomes

Measure
The lung infection rate within 14 days after stroke onset
time frame: 14 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Fudan University.