Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)Drug: Placebo
- Registration Number
- NCT00710164
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) - B Placebo -
- Primary Outcome Measures
Name Time Method Global disability on modified Rankin scale 90 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (20)
Department of Nuerology, The Second People's Hospital of Foshan city
🇨🇳Foshan, Guangdong, China
Department of Nuerology, Kunming General Hospital of Chengdu Military Command
🇨🇳Kunming, Chengdu, China
Department of Nuerology, The Second People's Hospital of Jiangmen city
🇨🇳Jiangmen, Guangdong, China
Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine
🇨🇳Liuzhou, Guangxi, China
Department of Nuerology, The First People's Hospital of Changsha city
🇨🇳Changsha, Hunan, China
Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University
🇨🇳Shanghai, Shanghai, China
Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Department of Integrative Medicine, Zhongshan hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Cangzhou Central Hospistal
🇨🇳Cangzhou, Hebei, China
Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine
🇨🇳Wuhan, Hubei, China
Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Department of Neurology, Huashan hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Zhongshan hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University
🇨🇳Shanghai, Shanghai, China
Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China