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
Recruitment status was Recruiting
Sponsor:
Fudan University
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
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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
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 Integrative Medicine, Zhongshan hospital, Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200021 | |
| Contact: Dingfang Cai | |
| 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 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, Changhai Hospital Affiliated to the Second Military Medical University | Recruiting |
| Shanghai, Shanghai, China, 200433 | |
| Contact: Yangtai Guan, MD | |
| 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 Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Not yet recruiting |
| Shanghai, Shanghai, China, 200021 | |
| Contact: Zhenglong Fang, 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 Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013