StrokePhase 4NCT02604654
Effectiveness and Safety of Yiqitongluo Granule for Stroke
A Phase 4 study testing Yiqitongluo granule in people with Stroke, run by Yi Yang.
Trial summary
The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Yiqitongluo granule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,197 participants
- Where
- No sites listed yet
- Study dates
- 29 Dec 2015to 6 Dec 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild and moderate ischemic stroke patient with 4-25 NIHSS score
- stable patients within 1 week to 3 months
- sign informed consent before study
Who cannot join
- CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
- severe disturbance of consciousness
- dysphagia
- TIA
- hemorrhagic diathesis
- patient with malignant tumor whose expected lifetime is less than 3 months
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- allergic constitution
- gestation period, lactation period, woman with the possibility or plan of pregnancy
- those who participated in other clinical trials within 3 months or taking part in other clinical trials
About this study
Official title: Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome
The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.
- Conditions
- Stroke
- Being tested
- Yiqitongluo granule
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yiqitongluo granuleDrug
administered after dissolved
| Study group | Role | What they receive |
|---|---|---|
| Yiqitongluo group | Experimental | Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks. Receives: Drug: Yiqitongluo granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Yiqitongluo for stroke measured by laboratory index
Measured: change from baseline laboratory index at 28(±7) days
Secondary outcomes (5)
Effect of Yiqitongluo for stroke with mRS
mRS: modified Rankin Scale
Measured: 90(±7) days
Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine
Measured: 28(±7) days
Effect of Yiqitongluo for stroke with NIHSS
NIHSS: the NIH stroke scale
Measured: 28(±7) days
Effect of Yiqitongluo for stroke with BI
BI: Barthel Index
Measured: 28(±7) days
Effect of Yiqitongluo for stroke with EQ-5D
The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
Measured: 28(±7) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start29 Dec 2015
- Primary completion5 Nov 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Shineway Pharmaceutical Co.,Ltd
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, Study chair, The First Hospital of Jilin UniversityZhenni Guo, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604654
- Sponsor's protocol ID
- SWYY-YQTLKL
- Status last verified
- Jul 2020
- First submitted
- 11 Nov 2015
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome
- ClinicalTrials.gov ID
- NCT02604654
- Acronym / sponsor ID
- SWYY-YQTLKL
- Conditions
- Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,197 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Collaborators
- Shineway Pharmaceutical Co.,Ltd
- Study start
- 29 Dec 2015 (actual)
- Primary completion
- 5 Nov 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 13 Nov 2015 (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 the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yiqitongluo group | Experimental | Drug: Yiqitongluo granuleYiqitongluo granule 12g each time, 3 times a daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild and moderate ischemic stroke patient with 4-25 NIHSS score
- stable patients within 1 week to 3 months
- sign informed consent before study
Key exclusion criteria (9 listed)
- CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
- severe disturbance of consciousness
- dysphagia
- TIA
- hemorrhagic diathesis
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 |
|---|---|---|
| Yiqitongluo granuleadministered after dissolved | Drug | Yiqitongluo group |
Primary outcome
Safety of Yiqitongluo for stroke measured by laboratory index
Time frame: change from baseline laboratory index at 28(±7) days
5 secondary outcomes
Effect of Yiqitongluo for stroke with mRS
Time frame: 90(±7) days
Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine
Time frame: 28(±7) days
Effect of Yiqitongluo for stroke with NIHSS
Time frame: 28(±7) days
Effect of Yiqitongluo for stroke with BI
Time frame: 28(±7) days
Effect of Yiqitongluo for stroke with EQ-5D
Time frame: 28(±7) 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 25 Aug 2021.
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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.
Yi Yang study chair
The First Hospital of Jilin University
Zhenni Guo study director
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yiqitongluo granule in people with Stroke, run by Yi Yang.
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 3 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Safety of Yiqitongluo for stroke measured by laboratory index (time frame: change from baseline laboratory index at 28(±7) 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 25 Aug 2021.