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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Nanjing University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569088
First Posted: December 6, 2007
Last Update Posted: July 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing University of Traditional Chinese Medicine
  Purpose
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.

Condition Intervention Phase
Stroke Drug: Chinese herbs formula Drug: Mannitol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "973" Project for Pathology of Traditional Chinese Medicine

Resource links provided by NLM:


Further study details as provided by Nanjing University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Chinese symptoms [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • blood loss determined by brain CT [ Time Frame: 21 days ]

Estimated Enrollment: 300
Study Start Date: November 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Active Comparator: A
just the current Modern Medicine therapy for stroke would be available in the arm.
Drug: Mannitol
250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569088


Contacts
Contact: Fang Ye, Dr. 8625-86798189 yeflm@yahoo.com.cn

Locations
China, Jiangsu
Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine Recruiting
Nanjing, Jiangsu, China
Contact: Fan Ye, Dr.    8625-86798189    yeflm@yahoo.com.cn   
Principal Investigator: Mianhua Wu, Dr.         
Sub-Investigator: Xueping Zhou, Dr.         
Sub-Investigator: Weifeng Guo, Dr.         
Sub-Investigator: Xizheng Gu, Dr.         
Sponsors and Collaborators
Nanjing University of Traditional Chinese Medicine
Investigators
Principal Investigator: Mianhua Wu, Dr. Nanjing Uinversity of Traditional Chinese Medicine
  More Information

Responsible Party: Mianhua Wu, Nanjing University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00569088     History of Changes
Other Study ID Numbers: 2006CB504807
First Submitted: November 28, 2007
First Posted: December 6, 2007
Last Update Posted: July 8, 2009
Last Verified: July 2009

Keywords provided by Nanjing University of Traditional Chinese Medicine:
hemorrhagic stroke
Chinese Medicine
pathogenesis
YURE

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs