Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 28, 2007

Last Updated Date

February 2, 2009

Start Date ^†

November 2007

Current Primary Outcome Measures ^†

Chinese symptoms [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00569088 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

blood loss determined by brain CT [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases

Official Title ^†

"973" Project for Pathology of Traditional Chinese Medicine

Brief Summary

The purpose of this study is to determine whether the Chinese herbs formula is effective in the treatment of hemorrhagic stroke and to find out Chinese pathogeny and pathogenesis in the disease.

Detailed Description

Blood stasis and blood heat are two pathogens in the theory system of Chinese Medicine, which can cause many diseases independently. But in internal intractable diseases, such as viral hepatitis, stroke, and epidemic hemorrhagic fever, blood stasis and blood heat always accompany with each other. So the hypothesis is raised that blood stasis with heat (YURE) is a compound pathogen and key pathogenesis in internal intractable diseases. This study was aimed to verify the role that the compound pathogen played in hemorrhagic stroke and to observe the progress of the key pathogenesis. A randomized and controlled trial would be conducted in five hospitals, where 300 hospitalized patients with hemorrhagic stroke in the acute phase would receive different intervention with basic modern medicine treatment or Chinese herbs formula combined with the former. The Chinese herbs formula, which was designed under the guidance of the theory system of Chinese Medicine, was supposed to cool blood heat and dissolve blood stasis. Clinical efficacy and safety would be evaluated after the 21-days intervention.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Stroke

Intervention ^†

Drug: Chinese herbs formula
Drug: Mannitol

Study Arms / Comparison Groups

Experimental: A combined treatment would be used in the arm.That means Chinese herb formula would be used with the current Modern Medicine therapy for stroke in this arm.
Active Comparator: just the current Modern Medicine therapy for stroke would be available in the arm.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

300

Estimated Completion Date

March 2010

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

clinical diagnosis of hemorrhagic stroke
hospitalized in 48 hours after hemorrhagic stroke happens

Exclusion Criteria:

Subarachnoid Hemorrhage
intracranial hemorrhage caused by tumor, trauma or blood diseases

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Fang Ye, Dr.

8625-86798189

yeflm@yahoo.com.cn

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00569088

Responsible Party

Mianhua Wu, Nanjing University of Traditional Chinese Medicine

Secondary IDs ^††

Study Sponsor ^†

Nanjing University of Traditional Chinese Medicine

Collaborators ^††

Investigators ^†

Principal Investigator:

Mianhua Wu, Dr.

Nanjing Uinversity of Traditional Chinese Medicine

Information Provided By

Nanjing University of Traditional Chinese Medicine

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.