Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke

Study Overview
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Brief Summary
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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.

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)<br>* 14 days of XSCR capsule<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* 14 days of Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global disability on modified Rankin scale |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |