Cerebral InfarctionPhase 4NCT00351806
AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine
A Phase 4 study testing Erigeron breviscapus injection, hua tuo zai zao wan (a herbal medicine pill) and Compound stroke herbal medicine (8 herbal) in people with Cerebral Infarction, run by Guangzhou University of Traditional Chinese Medicine at 22 sites in China.
Trial summary
The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Erigeron breviscapus injection, hua tuo zai zao wan (a herbal medicine pill) and Compound stroke herbal medicine (8 herbal)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 22 sitesChina
- Study dates
- Jul 2005to Nov 2006
- Phase
- Phase 4
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke diagnosis by CT/MRI scan
- Yin pattern of Traditional Chinese Medicine Theory
- 40-85 years old
- Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard
- NIHSS >=4;
- Glasgow coma scale (GCS) >=7;
- Modified Rankin Scale less than 2 degrees before onset of this stroke
- Informed consent signed by patient or his/her family
Who cannot join
- Hemorrhagic stroke;
- Coma, GCS<=7;
- Cerebral hernia;
- Serious heart, liver, lung, kidney functional failure;
- Gastrointestinal (GI) bleeding;
- Thrombolysis drugs or surgery was administrated to the patient;
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- Not cooperative with physician;
- Psychological disorder;
- Already taken part in other clinical drug trial within the past 3 months
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100700
The People's Hospital of Sichuan Province
Chengdu, Sichuan, 610072
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, 528000
2nd hospital of Zhongshan University
Guangzhou, Guangdong, 510120
Neurology Center, Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120
Zhejiang Province Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang
Jinan Hospital of Traditional Chinese Medicine
Jinan, Shandong
Ruikang Hospital of Traditional Chinese Medicine
Nanning, Guangxi, 530011
1st Hospital of Guangxi college of Traditional Chinese Medicine
Nanning, Guangxi, 530023
Longhua Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000
Yueyang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000
zhongshan hospital of Fudan Unversity
Shanghai, Shanghai Municipality, 200032
Huashan Hospital of Fudan Unveristy
Shanghai, Shanghai Municipality, 200040
Taizhou Hospital of Traditional Chinese Medicine
Taizhou, Jiangsu
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Ürümqi, Xinjiang, 830001
The 2nd Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
The teahing hospital of Hubei College of Traditional Chinese Medicine
Wuhan, Hubei, 430006
The Hosptial of Shanxi College of Traditional Chinese Medicine
Xian Yang, Shanxi, 712000
The 1st Hospital of He'nan College of Traditional Chinese Medicine
Zhengzhou, Henan, 450006
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong
About this study
Official title: AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine
The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.
Read the detailed description
The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and safety.
- Conditions
- Cerebral Infarction
- Being tested
- Erigeron breviscapus injection, hua tuo zai zao wan (a herbal medicine pill), Compound stroke herbal medicine (8 herbal)
- Keywords
- acute intracerebral infarction
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erigeron breviscapus injectionDrug
hua tuo zai zao wan (a herbal medicine pill)Drug
Compound stroke herbal medicine (8 herbal)Drug
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicine | Experimental | Not described Receives: Drug: Erigeron breviscapus injection; Drug: hua tuo zai zao wan (a herbal medicine pill); Drug: Compound stroke herbal medicine (8 herbal) |
| placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
death rate, Barthel Index
Secondary outcomes (5)
Glasgow Outcome Scale (GOS)
Modified Rankin Scale (mRS)
National Institute of Health Stroke Scale (NIHSS)
Stroke Specific Quality of Life (SSQOL)
Scale of Traditional Chinese Medicine (SSTCM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJul 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Longhui Yang, Chairmam, Study chair, Branch of Science and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351806
- Sponsor's protocol ID
- 2004BA721A02
- Status last verified
- Aug 2013
- First submitted
- 12 Jul 2006
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
Huang Y, Guo JW; Project Group for Demonstration Study of Syndrome Differentiation Protocol and Effect Evaluation of Acute Ischemic Stroke. Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke. Zhong Xi Yi Jie He Xue Bao. 2010 May;8(5):417-26. doi: 10.3736/jcim20100504.
PubMed 20456839
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AISTCM-The Pathological Pattern Differentiation and Outcome Measurement of Acute Ischemic Stroke Treated With Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT00351806
- Acronym / sponsor ID
- 2004BA721A02
- Conditions
- Cerebral Infarction
- Keywords
- acute intracerebral infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Nov 2006
- First posted
- 13 Jul 2006 (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.
The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.
Detailed description
The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine | Experimental | Drug: Erigeron breviscapus injection, Drug: hua tuo zai zao wan (a herbal medicine pill), Drug: Compound stroke herbal medicine (8 herbal) |
| placebo | Placebo comparator | – |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ischemic stroke diagnosis by CT/MRI scan
- Yin pattern of Traditional Chinese Medicine Theory
- 40-85 years old
- Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard
- NIHSS >=4;
Key exclusion criteria (9 listed)
- Hemorrhagic stroke;
- Coma, GCS<=7;
- Cerebral hernia;
- Serious heart, liver, lung, kidney functional failure;
- Gastrointestinal (GI) bleeding;
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 |
|---|---|---|
| Erigeron breviscapus injection | Drug | Chinese herbal medicine |
| hua tuo zai zao wan (a herbal medicine pill) | Drug | Chinese herbal medicine |
| Compound stroke herbal medicine (8 herbal) | Drug | Chinese herbal medicine |
Primary outcome
death rate, Barthel Index
5 secondary outcomes
Glasgow Outcome Scale (GOS)
Modified Rankin Scale (mRS)
National Institute of Health Stroke Scale (NIHSS)
Stroke Specific Quality of Life (SSQOL)
Scale of Traditional Chinese Medicine (SSTCM)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Derived from this study: PubMed 20456839Huang Y, Guo JW; Project Group for Demonstration Study of Syndrome Differentiation Protocol and Effect Evaluation of Acute Ischemic Stroke. Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke. Zhong Xi Yi Jie He Xue Bao. 2010 May;8(5):417-26. doi: 10.3736/jcim20100504.
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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.
Longhui Yang, Chairmam study chair
Branch of Science and Education
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erigeron breviscapus injection, hua tuo zai zao wan (a herbal medicine pill) and Compound stroke herbal medicine (8 herbal) in people with Cerebral Infarction, run by Guangzhou University of Traditional Chinese Medicine at 22 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death rate, Barthel Index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00351806, which also lists 1 linked publication.
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 7 Aug 2013.