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

Sponsors and Collaborators:	Fudan University Sizuo
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00710164

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Fudan University:

Primary Outcome Measures:

Global disability on modified Rankin scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

NIH stroke scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Barthel Index [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Syndrome score by Traditional Chinese Medicine (TCM) standard [ Time Frame: 90 days ] [ Designated as safety issue: No ]
mini-mental state examination (MMSE) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	September 2008

Arms	Assigned Interventions
A: Experimental	Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) 14 days of XSCR capsule
B: Placebo Comparator	Drug: Placebo 14 days of Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710164

Contacts

Contact: Dingfang Cai, MD

doctorcn@hotmail.com

Locations

China
Department of Integrative Medicine, Zhongshan hospital, Fudan University	Recruiting
Shanghai, China, 200021
Contact: Dingfang Cai
Department of Neurology, Huashan hospital, Fudan University	Not yet recruiting
Shanghai, China, 200040
Contact: Qiang Dong, MD
Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Recruiting
Shanghai, China, 200001
Contact: Yansheng Li
Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Recruiting
Shanghai, China, 200081
Contact: Shaoshi Wang, MD
Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University	Recruiting
Shanghai, China, 200433
Contact: Yangtai Guan, MD
Department of Nuerology, Shanghai Sixth People＇s Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Active, not recruiting
Shanghai, China, 200233
Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Recruiting
Shanghai, China, 200092
Contact: Zhenguo Liu, MD
Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University	Recruiting
Shanghai, China, 200003
Contact: Zhongxin Zhao, MD
Department of Nuerology, Tongji Hospital of Tongji University	Recruiting
Shanghai, China, 200065
Contact: Qing Zhan, MD
Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Recruiting
Shanghai, China, 200025
Contact: Shengdi Chen, MD
Department of Nuerology, Zhongshan hospital, Fudan University	Not yet recruiting
Shanghai, China, 200032
Contact: Wei Fan, MD
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Recruiting
Shanghai, China, 200032
Contact: Canxing Yuan, MD
Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Not yet recruiting
Shanghai, China, 200021
Contact: Zhenglong Fang, MD
China, Chengdu
Department of Nuerology, Kunming General Hospital of Chengdu Military Command	Recruiting
Kunming, Chengdu, China, 650032
Contact: Shixiang Liu, MD
China, Guangdong
Department of Nuerology, The Second People's Hospital of Foshan city	Recruiting
Foshan, Guangdong, China, 528000
Contact: Qingkun Zhou, MD
Department of Nuerology, The Second People's Hospital of Jiangmen city	Recruiting
Jiangmen, Guangdong, China, 529030
Contact: Qiong Zheng, MD
China, Guangxi
Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine	Recruiting
Liuzhou, Guangxi, China, 545001
Contact: Changjun Lu, MD
China, Hebei
Department of Nuerology, Cangzhou Central Hospistal	Recruiting
Cangzhou, Hebei, China, 060001
Contact: Junling Zhang, MD
China, Hubei
Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine	Recruiting
Wuhan, Hubei, China, 430061
Contact: Mengjiu Dong, MD
China, Hunan
Department of Nuerology, The First People's Hospital of Changsha city	Recruiting
Changsha, Hunan, China, 410005
Contact: Shenhui Zhu, MD

Sponsors and Collaborators

Fudan University

Sizuo

More Information

No publications provided

Responsible Party:	Fudan University ( Dr. Cai, Department of Integrative Medicine, Zhongshan hospital )
Study ID Numbers:	XSCR capsule-1
Study First Received:	July 1, 2008
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00710164 History of Changes
Health Authority:	China: Zhongshan hospital of Fudan University

Study placed in the following topic categories:

Dong Quai
Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on September 11, 2009