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

NCT ID: NCT00569088

Last Updated: 2009-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Chinese herbs formula

Intervention Type DRUG

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

A

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

Group Type ACTIVE_COMPARATOR

Mannitol

Intervention Type DRUG

250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days

Interventions

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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

Intervention Type DRUG

Mannitol

250 ml Mannitol Injection or Glycerin and Fructose Injection ,once a day, for 3-5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Nanjing University of Traditional Chinese Medicine

Principal Investigators

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Mianhua Wu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nanjing Uinversity of Traditional Chinese Medicine

Locations

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Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Ye, Dr.

Role: CONTACT

8625-86798189

Facility Contacts

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Fan Ye, Dr.

Role: primary

8625-86798189

Other Identifiers

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2006CB504807

Identifier Type: -

Identifier Source: org_study_id

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