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

Fudan University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Acute Ischemic Stroke

Treatments

Drug: Placebo

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00710164

XSCR capsule-1

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.