Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

November 15, 2018 updated by: Xiaofei Yu

A Multi-center, Randomized, Double-blind and Placebo-controlled Clinical Research of 2200 Cases in Improving Curative Effect of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind，placebo-controlled trial design project.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention，which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers，who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.

Study Type

Interventional

Enrollment (Actual)

2200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, Shanghai, China, 200000
        • Shanghai Seventh People's Hospital
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
      • Shanghai, Shanghai, China, 200020
        • North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University
      • Shanghai, Shanghai, China, 200021
        • Shanghai Putuo Central Hospital
      • Shanghai, Shanghai, China, 200021
        • Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200032
        • Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital affliated to Fudan University
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital affliated to Fudan University
      • Shanghai, Shanghai, China, 200040
        • Shanghai fifth People's Hospital affliated to Fudan University
      • Shanghai, Shanghai, China, 200050
        • Tongren Hospital affliated to Shanghai Jiao Tong University
      • Shanghai, Shanghai, China, 200065
        • Tongji Hospital
      • Shanghai, Shanghai, China, 200071
        • Shanghai Chinese Medicine Hospital
      • Shanghai, Shanghai, China, 200082
        • Shanghai Hospital of Integrative Medicine
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
      • Shanghai, Shanghai, China, 200120
        • Dongfang Hospital affliated to Tongji University
      • Shanghai, Shanghai, China, 200135
        • Pudong Gong Li Hospital of Shanghai
      • Shanghai, Shanghai, China, 200233
        • Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University
      • Shanghai, Shanghai, China, 200336
        • Changning Tongren Hospital of Shanghai
      • Shanghai, Shanghai, China, 201200
        • Pudong Hospital of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 201306
        • East Branch of Shanghai sixth People's Hospital
      • Shanghai, Shanghai, China, 201700
        • Qingpu Branch of Zhongshan Hospital affliated to Fudan University
      • Shanghai, Shanghai, China, 201999
        • Shanghai third People's Hospital affliated to Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult volunteers aged ≤ 90 years old, ≥18 years old；
  • Conforming to the diagnostic criteria of cerebral infarction under the 2010 version of Chinese Guidelines for Treatment of Acute Ischemic Stroke；
  • Conforming to diagnostic criteria of the stasis type of TCM on the ischemic stroke；
  • The onset of acute cerebral infarction ≥ 10 days；
  • Consciousness awake；
  • Volunteers agree to accept the program and sign informed consent.

Exclusion Criteria:

  • Excluding the patients of the yin deficiency type of ischemic stroke.The diagnostic criteria of Yin deficiency type of ischemic stroke is that sudden onset of disease；being signs or symptoms of of neurological deficit；CT or MRI examination showing intracranial ischemic lesions；Scarlet tongue；
  • The volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up；
  • Psychiatric patients；
  • Pregnants and lactating women；
  • Volunteers in other clinical trials；
  • Volunteers who are not suitable for this clinical trial according to the researchers for other reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time
Drug: Naoxintong Capsule
This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.
Other Names:
  • Chinese Herbal Compound
Active Comparator: Control group
On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Placebo capsule，which is identical with Naoxintong capsule in the appearance, shape, color and content, 2 times a day, three granule per time
Drug: Placebo
placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.
Other Names:
  • Placebo of Chinese Herbal Compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke recurrence rate and Stroke mortality
Time Frame: 2 years
Stroke recurrence rate and Stroke mortality
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 2 years
All-cause mortality
2 years
The incidence rate of myocardial infarction
Time Frame: 2 years
The incidence rate of myocardial infarction
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: 2 years
The incidence of adverse events
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaofei Yu

Collaborators

Shanghai Municipal Science and Technology Commission

Investigators

  • Study Chair: Xiao F Yu, Doctor, ShuGuang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimate)

January 9, 2015

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14401970300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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