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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Naoxintong Capsule
Placebo
Sponsored by
Xiaofei Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring ischemic stroke；Naoxintong Capsule

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai seventh People's Hospital
  • Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
  • North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University
  • Shanghai Putuo Central Hospital
  • Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine
  • Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine
  • Zhongshan Hospital affliated to Fudan University
  • Huashan Hospital affliated to Fudan University
  • Shanghai fifth People's Hospital affliated to Fudan University
  • Tongren Hospital affliated to Shanghai Jiao Tong University
  • Tongji Hospital
  • Shanghai Chinese Medicine Hospital
  • Shanghai tenth People's Hospital
  • Shanghai Hospital of Integrative Medicine
  • Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
  • Dongfang Hospital affliated to Tongji University
  • Pudong Gong Li Hospital of Shanghai
  • Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University
  • Changning Tongren Hospital of Shanghai
  • Changhai Hospital
  • Pudong Hospital of Traditional Chinese Medicine
  • East Branch of Shanghai sixth People's Hospital
  • Qingpu Branch of Zhongshan Hospital affliated to Fudan University
  • Shanghai third People's Hospital affliated to Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time

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

Outcomes

Primary Outcome Measures

Stroke recurrence rate and Stroke mortality
Stroke recurrence rate and Stroke mortality

Secondary Outcome Measures

All-cause mortality
All-cause mortality
The incidence rate of myocardial infarction
The incidence rate of myocardial infarction

Full Information

First Posted
January 6, 2015
Last Updated
November 15, 2018
Sponsor
Xiaofei Yu
Collaborators
Shanghai Municipal Science and Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02334969
Brief Title
Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaofei Yu
Collaborators
Shanghai Municipal Science and Technology Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke；Naoxintong Capsule

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
On the basis of the secondary prevention of ischemic stroke，Volunteers will be taken Naoxintong capsule, 2 times a day, three granule per time
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Naoxintong Capsule
Other Intervention Name(s)
Chinese Herbal Compound
Intervention Description
This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of Chinese Herbal Compound
Intervention Description
placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.
Primary Outcome Measure Information:
Title
Stroke recurrence rate and Stroke mortality
Description
Stroke recurrence rate and Stroke mortality
Time Frame
2 years
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
2 years
Title
The incidence rate of myocardial infarction
Description
The incidence rate of myocardial infarction
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
The incidence of adverse events
Description
The incidence of adverse events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao F Yu, Doctor
Organizational Affiliation
ShuGuang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai seventh People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Name
Shanghai Putuo Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200021
Country
China
Facility Name
Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200021
Country
China
Facility Name
Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital affliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital affliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai fifth People's Hospital affliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Tongren Hospital affliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Shanghai Chinese Medicine Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Shanghai tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Shanghai Hospital of Integrative Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200082
Country
China
Facility Name
Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Dongfang Hospital affliated to Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Pudong Gong Li Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200135
Country
China
Facility Name
Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Changning Tongren Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Pudong Hospital of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Facility Name
East Branch of Shanghai sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201306
Country
China
Facility Name
Qingpu Branch of Zhongshan Hospital affliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201700
Country
China
Facility Name
Shanghai third People's Hospital affliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201999
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11786451
Citation
Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71. Erratum In: BMJ 2002 Jan 19;324(7330):141.
Results Reference
result
PubMed Identifier
21125042
Citation
Hankey GJ. Ischaemic stroke--prevention is better than cure. J R Coll Physicians Edinb. 2010 Mar;40(1):56-63. doi: 10.4997/JRCPE.2010.111. No abstract available.
Results Reference
result
PubMed Identifier
17437989
Citation
Sobel M. Commentary. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Perspect Vasc Surg Endovasc Ther. 2007 Mar;19(1):87-9. doi: 10.1177/1531003507299489. No abstract available.
Results Reference
result
PubMed Identifier
16176495
Citation
Matchar DB, Samsa GP, Liu S. Cost-effectiveness of antiplatelet agents in secondary stroke prevention: the limits of certainty. Value Health. 2005 Sep-Oct;8(5):572-80. doi: 10.1111/j.1524-4733.2005.00050.x.
Results Reference
result
PubMed Identifier
18757238
Citation
Diener HC, Sacco RL, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study group. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008 Oct;7(10):875-84. doi: 10.1016/S1474-4422(08)70198-4. Epub 2008 Aug 29. Erratum In: Lancet Neurol. 2008 Nov;7(11):985.
Results Reference
result
PubMed Identifier
21502757
Citation
Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis. 2011;31(6):601-13. doi: 10.1159/000327035. Epub 2011 Apr 19.
Results Reference
result
PubMed Identifier
25394855
Citation
Jeng JS, Sun Y, Lee JT, Lin RT, Chen CH, Po HL, Lin HJ, Liu CH, Sun MH, Sun MC, Chern CM, Lien LM, Chiu HC, Hu HH, Chiou HY, Chen ST, Ma H, Hsu CY; SPAD Study Investigators. The efficacy and safety of cilostazol in ischemic stroke patients with peripheral arterial disease (SPAD): protocol of a randomized, double-blind, placebo-controlled multicenter trial. Int J Stroke. 2015 Jan;10(1):123-7. doi: 10.1111/ijs.12384. Epub 2014 Nov 14.
Results Reference
result
PubMed Identifier
25401325
Citation
Ikeda Y, Shimada K, Teramoto T, Uchiyama S, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Ishizuka N. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2510-20. doi: 10.1001/jama.2014.15690.
Results Reference
result
PubMed Identifier
36251140
Citation
Yu XF, Zhu XY, Yuan CX, Wu DH, Zhao YW, Yang JJ, Wang CD, Wu WW, Liu XY, Liu ZG, Nie ZY, Deng BQ, Bao H, Li LX, Wang CY, Zhang HZ, Zhang JS, Huang JH, Gong F, Wang MZ, Guo YM, Sun Y, Cai DF. Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial. Chin J Integr Med. 2022 Dec;28(12):1063-1071. doi: 10.1007/s11655-022-3586-8. Epub 2022 Oct 17.
Results Reference
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Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

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