Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases
"973" Project for Pathology of Traditional Chinese Medicine
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Nov 2007
Typical duration for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 28, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 8, 2009
July 1, 2009
2.4 years
November 28, 2007
July 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chinese symptoms
21 days
Secondary Outcomes (1)
blood loss determined by brain CT
21 days
Study Arms (2)
B
EXPERIMENTALA 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.
A
ACTIVE COMPARATORjust the current Modern Medicine therapy for stroke would be available in the arm.
Interventions
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
Eligibility Criteria
You may qualify if:
- clinical diagnosis of hemorrhagic stroke
- hospitalized in 48 hours after hemorrhagic stroke happens
You may not qualify if:
- Subarachnoid Hemorrhage
- intracranial hemorrhage caused by tumor, trauma or blood diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Internal Intractable Diseases, Nanjing University of Traditonal Chinese Medicine
Nanjing, Jiangsu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mianhua Wu, Dr.
Nanjing Uinversity of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2007
First Posted
December 6, 2007
Study Start
November 1, 2007
Primary Completion
April 1, 2010
Study Completion
December 1, 2010
Last Updated
July 8, 2009
Record last verified: 2009-07