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

Study Overview
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Brief Summary
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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
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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.

Official Title
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973 Project for Pathology of Traditional Chinese Medicine

Conditions
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Stroke

Intervention / Treatment
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* Drug: Chinese herbs formula
* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>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. | Drug: Chinese herbs formula<br>* The chinese herbs formula includes eight herbs,and they are Radix et Rhizoma Rhei Palmati(Rhubarb,10 grams),Cornu Bubali(Buffalo Horn,30 grams),Radix Paeoniae Bubra(Red Peony Root,15 grams),Cortex Moutan Radicis(Tree Peony Root-bark,10 grams),Radix Rehmanniae(Adhesive Rehmannia Root Tuber,20 grams),Pheretima Aspergillum(Earth-worm,10 grams),Radix Notoginseng(Sanchi,5 grams)and Rhizoma Acori Tarainowii(Tararinow Sweetflag Rhizome,10 grams). Boiled together. 150ml of the juice,p.o.,twice a day,for 28 days<br>|
| Active Comparator: A<br>just the current Modern Medicine therapy for stroke would be available in the arm. | Drug: Mannitol<br>* 250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese symptoms |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss determined by brain CT |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhagic stroke, Chinese Medicine, pathogenesis, YURE