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

NCT ID: NCT00710164

Last Updated: 2010-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)

Intervention Type DRUG

14 days of XSCR capsule

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

14 days of Placebo

Interventions

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XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)

14 days of XSCR capsule

Intervention Type DRUG

Placebo

14 days of Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sizuo

UNKNOWN

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Fudan University

Locations

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Department of Nuerology, Kunming General Hospital of Chengdu Military Command

Kunming, Chengdu, China

Site Status RECRUITING

Department of Nuerology, The Second People's Hospital of Foshan city

Foshan, Guangdong, China

Site Status RECRUITING

Department of Nuerology, The Second People's Hospital of Jiangmen city

Jiangmen, Guangdong, China

Site Status RECRUITING

Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine

Liuzhou, Guangxi, China

Site Status RECRUITING

Department of Nuerology, Cangzhou Central Hospistal

Cangzhou, Hebei, China

Site Status RECRUITING

Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine

Wuhan, Hubei, China

Site Status RECRUITING

Department of Nuerology, The First People's Hospital of Changsha city

Changsha, Hunan, China

Site Status RECRUITING

Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Integrative Medicine, Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Nuerology, Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Department of Neurology, Huashan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Department of Nuerology, Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dingfang Cai, MD

Role: CONTACT

Facility Contacts

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Shixiang Liu, MD

Role: primary

Qingkun Zhou, MD

Role: primary

Qiong Zheng, MD

Role: primary

Changjun Lu, MD

Role: primary

Junling Zhang, MD

Role: primary

Mengjiu Dong, MD

Role: primary

Shenhui Zhu, MD

Role: primary

Yansheng Li

Role: primary

Zhongxin Zhao, MD

Role: primary

Dingfang Cai

Role: primary

Zhenglong Fang, MD

Role: primary

Shengdi Chen, MD

Role: primary

Canxing Yuan, MD

Role: primary

Wei Fan, MD

Role: primary

Qiang Dong, MD

Role: primary

Qing Zhan, MD

Role: primary

Shaoshi Wang, MD

Role: primary

Zhenguo Liu, MD

Role: primary

Yangtai Guan, MD

Role: primary

Other Identifiers

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XSCR capsule-1

Identifier Type: -

Identifier Source: org_study_id

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