StrokeNCT00843765
Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke
A study testing acupuncture, massage and basic TCM treatment and rehabilitation and WM basic treatment in people with Stroke, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- acupuncture, massage and basic TCM treatment and rehabilitation and WM basic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,151 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Nov 2010
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According with the stroke diagnosis of Traditional Chinese Medicine
- According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations
- It has attacked in 7 days
- The assessment of scale of NIHSS:4-24 points
- Age: ≥ 35 years and ≤ 75 years
- Patients or their legal guardians sign informed consent form
Who cannot join
- The patients with ICH or cerebral hemorrhage or TIA
- It has attacked beyond 7 days
- Patients with stroke history and the mRS ≥ 2 points before this attack
- Mixed type of stroke (infarction after bleeding or bleeding after infarction)
- Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating
- Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding
- Women of pregnancy or breast-feeding
- Patients who are taking part in other clinical trials that will influence the results of this study
Trial locations and contacts
1 site in 1 country.
China1 site
China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700
About this study
Official title: Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.
Read the detailed description
As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.
- Conditions
- Stroke
- Being tested
- acupuncture, massage and basic TCM treatment, rehabilitation and WM basic treatment
- Keywords
- Stroke, Traditional Chinese Medicine, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture, massage and basic TCM treatmentOther
Also called 863 TCM project for ischemic stroke-TCM group
- During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education.
- After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes.
rehabilitation and WM basic treatmentOther
Also called 863 TCM project for ischemic stroke-WM group
there two steps:
- during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education
- After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet
| Study group | Role | What they receive |
|---|---|---|
| TCM integrated group | Active comparator | 800 patients with acupuncture, massage and basic Chinese medicine treatment Receives: Other: acupuncture, massage and basic TCM treatment |
| Western Medicine group | Active comparator | 400 patients with modern rehabilitation techniques and Western Medicine basic treatment Receives: Other: rehabilitation and WM basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS Stroke Scale, relapse rate
Measured: 360 days
Secondary outcomes (1)
adverse event
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startDec 2007
- Primary completionFeb 2009
- Study completionNov 2010
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 StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,151 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Xie Y m, Principal investigator, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843765
- Sponsor's protocol ID
- 2007AA02Z4B2
- Status last verified
- Feb 2012
- First submitted
- 12 Feb 2009
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.
PubMed 32324916
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00843765
- Acronym / sponsor ID
- 2007AA02Z4B2
- Conditions
- Stroke
- Keywords
- Stroke, Traditional Chinese Medicine, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,151 participants (actual)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, Beijing Tiantan Hospital
- Study start
- Dec 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Feb 2009 (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.
Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.
Detailed description
As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM integrated group | Active comparator | Other: acupuncture, massage and basic TCM treatment800 patients with acupuncture, massage and basic Chinese medicine treatment |
| Western Medicine group | Active comparator | Other: rehabilitation and WM basic treatment400 patients with modern rehabilitation techniques and Western Medicine basic treatment |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According with the stroke diagnosis of Traditional Chinese Medicine
- According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations
- It has attacked in 7 days
- The assessment of scale of NIHSS:4-24 points
- Age: ≥ 35 years and ≤ 75 years
Key exclusion criteria (8 listed)
- The patients with ICH or cerebral hemorrhage or TIA
- It has attacked beyond 7 days
- Patients with stroke history and the mRS ≥ 2 points before this attack
- Mixed type of stroke (infarction after bleeding or bleeding after infarction)
- Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating
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 |
|---|---|---|
| acupuncture, massage and basic TCM treatmentAlso: 863 TCM project for ischemic stroke-TCM group1. During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education. 2. After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes. | Other | TCM integrated group |
| rehabilitation and WM basic treatmentAlso: 863 TCM project for ischemic stroke-WM groupthere two steps: 1. during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education 2. After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet | Other | Western Medicine group |
Primary outcome
NIHSS Stroke Scale, relapse rate
Time frame: 360 days
1 secondary outcome
adverse event
Time frame: 360 days
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 15 Feb 2012.
- Derived from this study: PubMed 32324916Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Xie Y m principal investigator
China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture, massage and basic TCM treatment and rehabilitation and WM basic treatment in people with Stroke, run by China Academy of Chinese Medical Sciences at 1 site 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 6 inclusion and 8 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
NIHSS Stroke Scale, relapse rate (time frame: 360 days). 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 NCT00843765, 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 15 Feb 2012.