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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334969
• Other study ID #: 14401970300
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: November 2018
• Source: ShuGuang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.
• Placebo
placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Xiaofei Yu	Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

References & Publications (8)

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. Erratum in: BMJ 2002 Jan — View 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, Dahlöf B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, — View 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. — View 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 facto — View 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 — View 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. — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of adverse events	The incidence of adverse events	2 years
Primary	Stroke recurrence rate and Stroke mortality	Stroke recurrence rate and Stroke mortality	2 years
Secondary	All-cause mortality	All-cause mortality	2 years
Secondary	The incidence rate of myocardial infarction	The incidence rate of myocardial infarction	2 years

External Links

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