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

Acute Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00710164
• Other study ID #: XSCR capsule-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 1, 2008
• Last updated: May 27, 2010
• Start date: September 2008

Study information

• Verified date: September 2009
• Source: Fudan University
• Contact: Dingfang Cai, MD
• Email: doctorcn[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Zhongshan hospital of Fudan University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke

Intervention

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

Locations

Country	Name	City	State
China	Department of Nuerology, Cangzhou Central Hospistal	Cangzhou	Hebei
China	Department of Nuerology, The First People's Hospital of Changsha city	Changsha	Hunan
China	Department of Nuerology, The Second People's Hospital of Foshan city	Foshan	Guangdong
China	Department of Nuerology, The Second People's Hospital of Jiangmen city	Jiangmen	Guangdong
China	Department of Nuerology, Kunming General Hospital of Chengdu Military Command	Kunming	Chengdu
China	Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine	Liuzhou	Guangxi
China	Department of Integrative Medicine, Zhongshan hospital, Fudan University	Shanghai	Shanghai
China	Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University	Shanghai	Shanghai
China	Department of Neurology, Huashan hospital, Fudan University	Shanghai	Shanghai
China	Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	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, Changzheng Hospital Affiliated to the Second Military Medical University	Shanghai	Shanghai
China	Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Department of Nuerology, Tongji Hospital of Tongji University	Shanghai	Shanghai
China	Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Department of Nuerology, Zhongshan hospital, Fudan University	Shanghai	Shanghai
China	Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Sizuo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global disability on modified Rankin scale		90 days	No
Secondary	NIH stroke scale		90 days	No
Secondary	Barthel Index		90 days	No
Secondary	Syndrome score by Traditional Chinese Medicine (TCM) standard		90 days	No
Secondary	mini-mental state examination (MMSE)		90 days	No
Secondary	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	Yes