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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2007

Last Updated Date

July 7, 2009

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Chinese symptoms [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00569088 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

blood loss determined by brain CT [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

"973" Project for Pathology of Traditional Chinese Medicine

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Stroke

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Fang Ye, Dr.

8625-86798189

yeflm@yahoo.com.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00569088

Other Study ID Numbers ^ICMJE

2006CB504807

Has Data Monitoring Committee

Yes

Responsible Party

Mianhua Wu, Nanjing University of Traditional Chinese Medicine

Study Sponsor ^ICMJE

Nanjing University of Traditional Chinese Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mianhua Wu, Dr.

Nanjing Uinversity of Traditional Chinese Medicine

Information Provided By

Nanjing University of Traditional Chinese Medicine

Verification Date

July 2009

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

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