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

Fudan University130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Acute Ischemic Stroke

Interventions

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

14 days of XSCR capsule

PlaceboDRUG

14 days of Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Outcomes

Primary Outcomes

Global disability on modified Rankin scale

Time frame: 90 days

Secondary Outcomes

NIH stroke scale

Time frame: 90 days

Barthel Index

Time frame: 90 days

Syndrome score by Traditional Chinese Medicine (TCM) standard

Time frame: 90 days

mini-mental state examination (MMSE)

Time frame: 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

Time frame: 90 days

Central Contacts

Dingfang Cai, MD

CONTACT

doctorcn@hotmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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Department of Nuerology, The First People's Hospital of Changsha city

Changsha, Hunan, China

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Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University

Shanghai, Shanghai Municipality, China

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Department of Integrative Medicine, Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

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...and 10 more locations