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

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ClinicalTrials.gov Identifier: NCT02334969
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
Shanghai Municipal Science and Technology Commission
Information provided by (Responsible Party):
Xiaofei Yu, ShuGuang Hospital

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Naoxintong Capsule Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

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 Name: 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 Name: Placebo of Chinese Herbal Compound




Primary Outcome Measures :
  1. Stroke recurrence rate and Stroke mortality [ Time Frame: 2 years ]
    Stroke recurrence rate and Stroke mortality


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 2 years ]
    All-cause mortality

  2. The incidence rate of myocardial infarction [ Time Frame: 2 years ]
    The incidence rate of myocardial infarction


Other Outcome Measures:
  1. The incidence of adverse events [ Time Frame: 2 years ]
    The incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334969


Locations
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China, Shanghai
Shanghai seventh People's Hospital
Shanghai, Shanghai, China, 200000
Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
Shanghai, Shanghai, China, 200011
North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200020
Shanghai Putuo Central Hospital
Shanghai, Shanghai, China, 200021
Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200021
Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200032
Zhongshan Hospital affliated to Fudan University
Shanghai, Shanghai, China, 200032
Huashan Hospital affliated to Fudan University
Shanghai, Shanghai, China, 200040
Shanghai fifth People's Hospital affliated to Fudan University
Shanghai, Shanghai, China, 200040
Tongren Hospital affliated to Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200050
Tongji Hospital
Shanghai, Shanghai, China, 200065
Shanghai Chinese Medicine Hospital
Shanghai, Shanghai, China, 200071
Shanghai tenth People's Hospital
Shanghai, Shanghai, China, 200072
Shanghai Hospital of Integrative Medicine
Shanghai, Shanghai, China, 200082
Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
Shanghai, Shanghai, China, 200092
Dongfang Hospital affliated to Tongji University
Shanghai, Shanghai, China, 200120
Pudong Gong Li Hospital of Shanghai
Shanghai, Shanghai, China, 200135
Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200233
Changning Tongren Hospital of Shanghai
Shanghai, Shanghai, China, 200336
Changhai Hospital
Shanghai, Shanghai, China, 200433
Pudong Hospital of Traditional Chinese Medicine
Shanghai, Shanghai, China, 201200
East Branch of Shanghai sixth People's Hospital
Shanghai, Shanghai, China, 201306
Qingpu Branch of Zhongshan Hospital affliated to Fudan University
Shanghai, Shanghai, China, 201700
Shanghai third People's Hospital affliated to Shanghai Jiao Tong University
Shanghai, Shanghai, China, 201999
Sponsors and Collaborators
Xiaofei Yu
Shanghai Municipal Science and Technology Commission
Investigators
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Study Chair: Xiao F Yu, Doctor ShuGuang Hospital

Additional Information:
Publications of Results:
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, Dahlöf 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.

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Responsible Party: Xiaofei Yu, Shuguang Hospital, ShuGuang Hospital
ClinicalTrials.gov Identifier: NCT02334969     History of Changes
Other Study ID Numbers: 14401970300
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiaofei Yu, ShuGuang Hospital:
ischemic stroke;Naoxintong Capsule
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia