Acute Ischemic StrokePhase 2/3NCT00710164
Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke
A Phase 2/3 study testing XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) in people with Acute Ischemic Stroke, run by Fudan University at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 20 sitesChina
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
Dingfang Cai, MD contact
20 sites in 1 country
China20 sites, 19 recruiting
- Recruiting
Department of Nuerology, Cangzhou Central Hospistal
Cangzhou, Hebei, 060001
Junling Zhang, MD
- Recruiting
Department of Nuerology, The First People's Hospital of Changsha city
Changsha, Hunan, 410005
Shenhui Zhu, MD
- Recruiting
Department of Nuerology, The Second People's Hospital of Foshan city
Foshan, Guangdong, 528000
Qingkun Zhou, MD
- Recruiting
Department of Nuerology, The Second People's Hospital of Jiangmen city
Jiangmen, Guangdong, 529030
Qiong Zheng, MD
- Recruiting
Department of Nuerology, Kunming General Hospital of Chengdu Military Command
Kunming, Chengdu, 650032
Shixiang Liu, MD
- Recruiting
Department of Nuerology, Liuzhou Hospital of Traditional Chinese Medicine
Liuzhou, Guangxi, 545001
Changjun Lu, MD
- Recruiting
Department of Neurology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200001
Yansheng Li
- Recruiting
Department of Nuerology, Changzheng Hospital Affiliated to the Second Military Medical University
Shanghai, Shanghai Municipality, 200003
Zhongxin Zhao, MD
- Recruiting
Department of Integrative Medicine, Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200021
Dingfang Cai
- Not yet recruiting
Department of Nuerology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200021
Zhenglong Fang, MD
- Recruiting
Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Shengdi Chen, MD
- Recruiting
Department of Nuerology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Canxing Yuan, MD
- Not yet recruiting
Department of Nuerology, Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Wei Fan, MD
- Not yet recruiting
Department of Neurology, Huashan hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Qiang Dong, MD
- Recruiting
Department of Nuerology, Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Qing Zhan, MD
- Recruiting
Department of Neurology, Shanghai First People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200081
Shaoshi Wang, MD
- Recruiting
Department of Nuerology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Zhenguo Liu, MD
- Active, not recruiting
Department of Nuerology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200233
- Recruiting
Department of Neurology, Changhai Hospital Affiliated to the Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Yangtai Guan, MD
- Recruiting
Department of Nuerology, Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430061
Mengjiu Dong, MD
About this study
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.), Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)Drug
14 days of XSCR capsule
PlaceboDrug
14 days of Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global disability on modified Rankin scale
Measured: 90 days
Secondary outcomes (5)
NIH stroke scale
Measured: 90 days
Barthel Index
Measured: 90 days
Syndrome score by Traditional Chinese Medicine (TCM) standard
Measured: 90 days
mini-mental state examination (MMSE)
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sizuo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710164
- Sponsor's protocol ID
- XSCR capsule-1
- Status last verified
- Sep 2009
- First submitted
- 1 Jul 2008
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule for the Treatment of Patients Who Have Suffered From a Stroke
- ClinicalTrials.gov ID
- NCT00710164
- Acronym / sponsor ID
- XSCR capsule-1
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Sizuo
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (estimated)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.)14 days of XSCR capsule | Drug | A |
| Placebo14 days of Placebo | Drug | B |
Primary outcome
Global disability on modified Rankin scale
Time frame: 90 days
5 secondary outcomes
NIH stroke scale
Time frame: 90 days
Barthel Index
Time frame: 90 days
Syndrome score by Traditional Chinese Medicine (TCM) standard
Time frame: 90 days
mini-mental state examination (MMSE)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dingfang Cai, MD contact
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) in people with Acute Ischemic Stroke, run by Fudan University at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingfang Cai, MD (doctorcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global disability on modified Rankin scale (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.