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

July 7, 2009 updated by: Nanjing University of Traditional Chinese Medicine

"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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Mianhua Wu, Dr.
        • Sub-Investigator:
          • Xueping Zhou, Dr.
        • Sub-Investigator:
          • Weifeng Guo, Dr.
        • Sub-Investigator:
          • Xizheng Gu, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chinese symptoms
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
blood loss determined by brain CT
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Mianhua Wu, Dr., Nanjing Uinversity of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 28, 2007

First Submitted That Met QC Criteria

December 5, 2007

First Posted (Estimate)

December 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006CB504807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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