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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sizuo
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00710164
First received: July 1, 2008
Last updated: May 27, 2010
Last verified: September 2009
  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 2
Phase 3

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

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
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)
14 days of XSCR capsule
Placebo Comparator: B 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Dingfang Cai, MD doctorcn@hotmail.com

Locations
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         
China, Shanghai
Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200081
Contact: Shaoshi Wang, MD         
Department of Neurology, Huashan hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Qiang Dong, MD         
Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200001
Contact: Yansheng Li         
Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Not yet recruiting
Shanghai, Shanghai, China, 200021
Contact: Zhenglong Fang, MD         
Department of Integrative Medicine, Zhongshan hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200021
Contact: Dingfang Cai         
Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Shengdi Chen, MD         
Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Zhenguo Liu, MD         
Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University Recruiting
Shanghai, Shanghai, China, 200003
Contact: Zhongxin Zhao, MD         
Department of Nuerology, Tongji Hospital of Tongji University Recruiting
Shanghai, Shanghai, China, 200065
Contact: Qing Zhan, MD         
Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine Active, not recruiting
Shanghai, Shanghai, China, 200233
Department of Nuerology, Zhongshan hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Wei Fan, MD         
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Canxing Yuan, MD         
Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University Recruiting
Shanghai, Shanghai, China, 200433
Contact: Yangtai Guan, MD         
Sponsors and Collaborators
Fudan University
Sizuo
  More Information

No publications provided

Responsible Party: Dr. Cai, Department of Integrative Medicine, Zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00710164     History of Changes
Other Study ID Numbers: XSCR capsule-1
Study First Received: July 1, 2008
Last Updated: May 27, 2010
Health Authority: China: Zhongshan hospital of Fudan University

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014