Clinical trial NCT00710164: Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Ischemic Stroke
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Sizuo
First posted: 2008-07-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke with limb weakness, NIH stroke scale ≥6, limb weakness score ≥2
* Onset of symptoms within 72 hours
* 18 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

Exclusion Criteria:

* 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)
* Had been participated in other clinical trials during the last 1 month prior to study inclusion.

Primary outcomes:
measure: Global disability on modified Rankin scale
timeFrame: 90 days
Secondary outcomes:
measure: NIH stroke scale
timeFrame: 90 days
measure: Barthel Index
timeFrame: 90 days
measure: Syndrome score by Traditional Chinese Medicine (TCM) standard
timeFrame: 90 days
measure: mini-mental state examination (MMSE)
timeFrame: 90 days
measure: 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
timeFrame: 90 days
Other outcomes:
Locations:
city: Kunming
country: China
facility: Department of Nuerology, Kunming General Hospital of Chengdu Military Command
state: Chengdu
city: Foshan
country: China
facility: Department of Nuerology, The Second People's Hospital of Foshan city
state: Guangdong
city: Jiangmen
country: China
facility: Department of Nuerology, The Second People's Hospital of Jiangmen city
state: Guangdong
city: Liuzhou
country: China
facility: Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine
state: Guangxi
city: Cangzhou
country: China
facility: Department of Nuerology, Cangzhou Central Hospistal
state: Hebei
city: Wuhan
country: China
facility: Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine
state: Hubei
city: Changsha
country: China
facility: Department of Nuerology, The First People's Hospital of Changsha city
state: Hunan
city: Shanghai
country: China
facility: Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Department of Integrative Medicine, Zhongshan hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Zhongshan hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Department of Neurology, Huashan hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Tongji Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University
state: Shanghai
Study officials:
References: