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Tracking Information | |||||
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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. |
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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. |
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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 † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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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:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 40 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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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 † |
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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. |