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| Name | Class |
|---|---|
| Liaocheng People's Hospital | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
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Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial
Intracranial artery stenosis (ICAS) is a common cause of ischemic stroke worldwide. At present, percutaneous transluminal angioplasty and stenting serve as a possible treatment option for ICAS patients, however, intracranial in-stent restenosis(ISR) limited its use in clinical practice, which led to recurrent stroke even death, meanwhile, From the point of chinese medicine, in-stent restenosis(ISR) regard as the unhealthy environmental influences with shapes, therefore, we have design two control group on the basis of conventional secondary prevention, one use herbal medicine for blood-acting and stasis-dissolving, and another use the similar looking placebos, after 12 months of treatment, we will evaluate the rate of all-cause stroke and all-cause mortality, moreover, we also record the Vascular restenosis rate which may cause recurrent ischemic stroke, the aim of this study was to evaluate the safety and efficacy of herbal medicine C-117.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herbal Medicine C-117 | Experimental | Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year |
|
| The Placebo of Herbal Medicine C-117 | Placebo Comparator | The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal Medicine C-117 | Drug | C117 formula including 2 herbals and 2 insects |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the total number of all-cause mortality and all-cause stroke within 12 months | After drug-use 12 months,observe all-cause mortality and all-cause stroke(hemorrhage or ischemic). | After 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of intracranial in-stent restenosis | After drug-use 12 months,observe the rate of intracranial in-stent restenosis where stent implantation.throgh the test of TCD, digital subtraction angiography. | After 12 months follow-up period,record the rate of intracranial in-stent restenosis |
| The complications of intracranial in-stent restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianwen Guo, doctor | Contact | 0086-13724899379 | jianwen_guo@msn.com | |
| jianwen guo, MD | Contact | (08620)81887233 | 30906 | 306247680@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingguang Zhang, MD | Guangdong Province Hospital of Tradtional Chinese Medicine | Principal Investigator |
| Zhangyong Xia, MD | Liaocheng People's Hospital | Principal Investigator |
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| The Placebo of Herbal Medicine C-117 |
| Drug |
|
After drug-use 12 months,observe the complications of intracranial in-stent restenosis,including TIA and stroke,even death. |
| After 12 months follow-up period,record the complications of intracranial in-stent restenosis |
| NIH Stroke Scale (NIHSS) | At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS | After 12 months follow-up period |
| Bathel index | At the time of 6 and 12 months,we will have a follow-up to assess the patient's NIHSS, Bathel index | After 12 months follow-up period |
| modified RANKIN score. | modified RANKIN score. | After 12 months follow-up period |
| Jian Yang, MD |
| Liaoning Cancer Hospital & Institute |
| Principal Investigator |
| Wentong Ling, MD | Zhangshan People's Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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