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

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chinese herbs formula
Mannitol
Sponsored by
Nanjing University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring hemorrhagic stroke, Chinese Medicine, pathogenesis, YURE

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

B

A

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Chinese symptoms

Secondary Outcome Measures

blood loss determined by brain CT

Full Information

First Posted
November 28, 2007
Last Updated
July 7, 2009
Sponsor
Nanjing University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00569088
Brief Title
Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
Official Title
"973" Project for Pathology of Traditional Chinese Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
hemorrhagic stroke, Chinese Medicine, pathogenesis, YURE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
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.
Arm Title
A
Arm Type
Active Comparator
Arm Description
just the current Modern Medicine therapy for stroke would be available in the arm.
Intervention Type
Drug
Intervention Name(s)
Chinese herbs formula
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days
Primary Outcome Measure Information:
Title
Chinese symptoms
Time Frame
21 days
Secondary Outcome Measure Information:
Title
blood loss determined by brain CT
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Ye, Dr.
Phone
8625-86798189
Email
yeflm@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mianhua Wu, Dr.
Organizational Affiliation
Nanjing Uinversity of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Ye, Dr.
Phone
8625-86798189
Email
yeflm@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Mianhua Wu, Dr.
First Name & Middle Initial & Last Name & Degree
Xueping Zhou, Dr.
First Name & Middle Initial & Last Name & Degree
Weifeng Guo, Dr.
First Name & Middle Initial & Last Name & Degree
Xizheng Gu, Dr.

12. IPD Sharing Statement

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

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