DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Nanjing University of Traditional Chinese Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stroke

Intervention: Chinese herbs formula (Drug); Mannitol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Nanjing University of Traditional Chinese Medicine

Official(s) and/or principal investigator(s):
Mianhua Wu, Dr., Principal Investigator, Affiliation: Nanjing Uinversity of Traditional Chinese Medicine

Overall contact:
Fang Ye, Dr., Phone: 8625-86798189, Email: yeflm@yahoo.com.cn

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.

Clinical Details

Official title: "973" Project for Pathology of Traditional Chinese Medicine

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

Primary outcome: Chinese symptoms

Secondary outcome: blood loss determined by brain CT

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

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Fang Ye, Dr., Phone: 8625-86798189, Email: yeflm@yahoo.com.cn

Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine, Nanjing, Jiangsu, China; Recruiting
Fan Ye, Dr., Phone: 8625-86798189, Email: yeflm@yahoo.com.cn
Mianhua Wu, Dr., Principal Investigator
Xueping Zhou, Dr., Sub-Investigator
Weifeng Guo, Dr., Sub-Investigator
Xizheng Gu, Dr., Sub-Investigator
Additional Information

Starting date: November 2007
Last updated: July 7, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017