Clinical trial NCT02334969: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: ischemic stroke；Naoxintong Capsule
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
First posted: 2015-01-09
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Stroke recurrence rate and Stroke mortality
timeFrame: 2 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 2 years
measure: The incidence rate of myocardial infarction
timeFrame: 2 years
Other outcomes:
measure: The incidence of adverse events
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Shanghai seventh People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
state: Shanghai
city: Shanghai
country: China
facility: North Branch of Ruijin Hospital affliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Putuo Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital affliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital affliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital affliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital affliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai fifth People's Hospital affliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Tongren Hospital affliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chinese Medicine Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Hospital of Integrative Medicine
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital affliated to Shanghai Jiao Tong University Shool of Medcine
state: Shanghai
city: Shanghai
country: China
facility: Dongfang Hospital affliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Pudong Gong Li Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Shanghai sixth People's Hospital affliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Changning Tongren Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Pudong Hospital of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: East Branch of Shanghai sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Qingpu Branch of Zhongshan Hospital affliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai third People's Hospital affliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: ShuGuang Hospital
name: Xiao F Yu, Doctor
role: STUDY_CHAIR
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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.