Acute Ischemic Stroke
Conditions
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.
Interventions
DRUGXSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)
14 days of XSCR capsule
DRUGPlacebo
14 days of Placebo
Sponsors
Sizuo
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global disability on modified Rankin scale | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactDingfang Cai, MD
Outcome results
None listed