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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Nanjing University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nanjing University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00569088
First received: November 28, 2007
Last updated: July 7, 2009
Last verified: July 2009

November 28, 2007
July 7, 2009
November 2007
April 2010   (final data collection date for primary outcome measure)
Chinese symptoms [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00569088 on ClinicalTrials.gov Archive Site
blood loss determined by brain CT [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
"973" Project for Pathology of Traditional Chinese Medicine

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • 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
  • Experimental: B
    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.
    Intervention: Drug: Chinese herbs formula
  • Active Comparator: A
    just the current Modern Medicine therapy for stroke would be available in the arm.
    Intervention: Drug: Mannitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact: Fang Ye, Dr. 8625-86798189 yeflm@yahoo.com.cn
China
 
NCT00569088
2006CB504807
Yes
Mianhua Wu, Nanjing University of Traditional Chinese Medicine
Nanjing University of Traditional Chinese Medicine
Not Provided
Principal Investigator: Mianhua Wu, Dr. Nanjing Uinversity of Traditional Chinese Medicine
Nanjing University of Traditional Chinese Medicine
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP