Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
- Registration Number
- NCT00569088
- Lead Sponsor
- Nanjing University 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- clinical diagnosis of hemorrhagic stroke
- hospitalized in 48 hours after hemorrhagic stroke happens
- Subarachnoid Hemorrhage
- intracranial hemorrhage caused by tumor, trauma or blood diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Chinese herbs formula 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. A Mannitol just the current Modern Medicine therapy for stroke would be available in the arm.
- Primary Outcome Measures
Name Time Method Chinese symptoms 21 days
- Secondary Outcome Measures
Name Time Method blood loss determined by brain CT 21 days
Trial Locations
- Locations (1)
Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine
🇨🇳Nanjing, Jiangsu, China