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

Nanjing University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Stroke

Treatments: Drug: Mannitol; Drug: Chinese herbs formula

Study type: Interventional

Funder types: Other

Identifiers

NCT00569088

2006CB504807

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

B

Experimental group

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.

Treatment:

Drug: Chinese herbs formula

A

Active Comparator group

Description:

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

Treatment:

Drug: Mannitol