Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
Information source: Nanjing University of Traditional Chinese Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke
Intervention: Chinese herbs formula (Drug); Mannitol (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Nanjing University of Traditional Chinese Medicine Official(s) and/or principal investigator(s): Mianhua Wu, Dr., Principal Investigator, Affiliation: Nanjing Uinversity of Traditional Chinese Medicine
Overall contact: Fang Ye, Dr., Phone: 8625-86798189, Email: yeflm@yahoo.com.cn
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.
Clinical Details
Official title: "973" Project for Pathology of Traditional Chinese Medicine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Chinese symptoms
Secondary outcome: blood loss determined by brain CT
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Fang Ye, Dr., Phone: 8625-86798189, Email: yeflm@yahoo.com.cn
Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine, Nanjing, Jiangsu, China; Recruiting Fan Ye, Dr., Phone: 8625-86798189, Email: yeflm@yahoo.com.cn Mianhua Wu, Dr., Principal Investigator Xueping Zhou, Dr., Sub-Investigator Weifeng Guo, Dr., Sub-Investigator Xizheng Gu, Dr., Sub-Investigator
Additional Information
Starting date: November 2007
Last updated: July 7, 2009
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