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

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)
Placebo
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Nuerology, Kunming General Hospital of Chengdu Military CommandRecruiting
  • Department of Nuerology, The Second People's Hospital of Foshan cityRecruiting
  • Department of Nuerology, The Second People's Hospital of Jiangmen cityRecruiting
  • Department of Nuerology, Liuzhou Hospital of Traditional Chinese MedicineRecruiting
  • Department of Nuerology, Cangzhou Central HospistalRecruiting
  • Department of Nuerology, Hubei Hospital of Traditional Chinese MedicineRecruiting
  • Department of Nuerology, The First People's Hospital of Changsha cityRecruiting
  • Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical UniversityRecruiting
  • Department of Integrative Medicine, Zhongshan hospital, Fudan UniversityRecruiting
  • Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineRecruiting
  • Department of Nuerology, Zhongshan hospital, Fudan University
  • Department of Neurology, Huashan hospital, Fudan University
  • Department of Nuerology, Tongji Hospital of Tongji UniversityRecruiting
  • Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
  • Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Global disability on modified Rankin scale

Secondary Outcome Measures

NIH stroke scale
Barthel Index
Syndrome score by Traditional Chinese Medicine (TCM) standard
mini-mental state examination (MMSE)
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

Full Information

First Posted
July 1, 2008
Last Updated
May 27, 2010
Sponsor
Fudan University
Collaborators
Sizuo
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1. Study Identification

Unique Protocol Identification Number
NCT00710164
Brief Title
Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University
Collaborators
Sizuo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)
Intervention Description
14 days of XSCR capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
14 days of Placebo
Primary Outcome Measure Information:
Title
Global disability on modified Rankin scale
Time Frame
90 days
Secondary Outcome Measure Information:
Title
NIH stroke scale
Time Frame
90 days
Title
Barthel Index
Time Frame
90 days
Title
Syndrome score by Traditional Chinese Medicine (TCM) standard
Time Frame
90 days
Title
mini-mental state examination (MMSE)
Time Frame
90 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dingfang Cai, MD
Email
doctorcn@hotmail.com
Facility Information:
Facility Name
Department of Nuerology, Kunming General Hospital of Chengdu Military Command
City
Kunming
State/Province
Chengdu
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shixiang Liu, MD
Facility Name
Department of Nuerology, The Second People's Hospital of Foshan city
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingkun Zhou, MD
Facility Name
Department of Nuerology, The Second People's Hospital of Jiangmen city
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiong Zheng, MD
Facility Name
Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changjun Lu, MD
Facility Name
Department of Nuerology, Cangzhou Central Hospistal
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
060001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junling Zhang, MD
Facility Name
Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengjiu Dong, MD
Facility Name
Department of Nuerology, The First People's Hospital of Changsha city
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenhui Zhu, MD
Facility Name
Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yansheng Li
Facility Name
Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongxin Zhao, MD
Facility Name
Department of Integrative Medicine, Zhongshan hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingfang Cai
Facility Name
Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenglong Fang, MD
Facility Name
Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengdi Chen, MD
Facility Name
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canxing Yuan, MD
Facility Name
Department of Nuerology, Zhongshan hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Fan, MD
Facility Name
Department of Neurology, Huashan hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Dong, MD
Facility Name
Department of Nuerology, Tongji Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Zhan, MD
Facility Name
Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoshi Wang, MD
Facility Name
Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenguo Liu, MD
Facility Name
Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangtai Guan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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