Prevention for the Restenosis of Intracranial Artery Stent Implantation Treated With Herbal Medicine C117

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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Prevention for the Restenosis of Intracranial artery Stent Implantation Treated with herbal medicine C117--PRISIT Trial

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Detailed Description

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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.

Conditions

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Occlusion and Stenosis of Unspecified Cerebral Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Herbal Medicine C-117

Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year

Group Type EXPERIMENTAL

Herbal Medicine C-117

Intervention Type DRUG

C117 formula including 2 herbals and 2 insects

The Placebo of Herbal Medicine C-117

The Placebo of Herbal Medicine C-117 6g granules by mouth,every 12 hours for 1 year

Group Type PLACEBO_COMPARATOR

The Placebo of Herbal Medicine C-117

Intervention Type DRUG

Interventions

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Herbal Medicine C-117

C117 formula including 2 herbals and 2 insects

Intervention Type DRUG

The Placebo of Herbal Medicine C-117

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Older than 18 years of age
2. 70-90% stenosis of intracranial responsible angiopathic area under the DSA angiography (as judged through the WASID method);after operation vascular stenosis less than 50%.
3. The score of mRS≤3
4. To rule out intracranial hemorrhage by CT orMRI
5. Adhere to the medication

Exclusion Criteria

1. Together with intracranial tumors or AVM
2. The lesion area where implant stent previons
3. Fetch intracranial artery thrombus by emergency surgical operation
4. Vascular serious circuity
5. Myocardial infarction need to antithrombotic
6. MoyaMoya disease or cerebral vasculitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No