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

May 27, 2010 updated by: Fudan University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global disability on modified Rankin scale
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
NIH stroke scale
Time Frame: 90 days
90 days
Barthel Index
Time Frame: 90 days
90 days
Syndrome score by Traditional Chinese Medicine (TCM) standard
Time Frame: 90 days
90 days
mini-mental state examination (MMSE)
Time Frame: 90 days
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Sizuo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XSCR capsule-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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