Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke
1 other identifier
interventional
130
1 country
20
Brief Summary
This study will determine if Xiaoshuanchangrong (XSCR) capsule will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
20 active sites
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
First Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 4, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedMay 28, 2010
September 1, 2009
1.8 years
July 1, 2008
May 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Global disability on modified Rankin scale
90 days
Secondary Outcomes (5)
NIH stroke scale
90 days
Barthel Index
90 days
Syndrome score by Traditional Chinese Medicine (TCM) standard
90 days
mini-mental state examination (MMSE)
90 days
Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase(AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b
90 days
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
14 days of XSCR capsule
Eligibility Criteria
You may qualify if:
- Acute ischemic stroke with limb weakness, NIH stroke scale ≥6, limb weakness score ≥2
- Onset of symptoms within 72 hours
- Years and older
- Consistent with the Qi deficiency and Blood stasis type by Traditional Chinese Medicine (TCM) standard
- Patients or their representatives voluntarily take part in this study and signed the informed consent
You may not qualify if:
- Transient ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
- Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
- Pregnant or breast-feeding.
- Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap.
- Liable to be allergic (allergic to at lease 2 foods/drugs previously exposed)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Sizuocollaborator
Study Sites (20)
Department of Nuerology, Kunming General Hospital of Chengdu Military Command
Kunming, Chengdu, 650032, China
Department of Nuerology, The Second People's Hospital of Foshan city
Foshan, Guangdong, 528000, China
Department of Nuerology, The Second People's Hospital of Jiangmen city
Jiangmen, Guangdong, 529030, China
Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine
Liuchow, Guangxi, 545001, China
Department of Nuerology, Cangzhou Central Hospistal
Cangzhou, Hebei, 060001, China
Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430061, China
Department of Nuerology, The First People's Hospital of Changsha city
Changsha, Hunan, 410005, China
Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001, China
Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University
Shanghai, Shanghai Municipality, 200003, China
Department of Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200021, China
Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200021, China
Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Department of Nuerology, Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Department of Neurology, Huashan hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Department of Nuerology, Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200081, China
Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200233, China
Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 4, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2010
Last Updated
May 28, 2010
Record last verified: 2009-09