Trial | NCT00569088  Report issue

Title

Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
"973" Project for Pathology of Traditional Chinese Medicine

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    300
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.
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 Started
Nov 30
2007
Primary Completion
Apr 30
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Jul 08
2009
Estimate

Drug Chinese herbs formula

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

Drug Mannitol

250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days

B 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.

A Active Comparator

just the current Modern Medicine therapy for stroke would be available in the arm.

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
No Results Posted