Coronary Heart Disease Clinical Trial
Official title:
Efficacy and Safety of Chinese Herbal Medicine Wen Xin Granules for the Treatment of Unstable Angina Pectoris With Yang Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Controlled Trial
This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.
Status | Not yet recruiting |
Enrollment | 502 |
Est. completion date | June 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility | Inclusion Criteria: - aged between 35 and 75 years of age; - diagnosed with CAD through coronary arteriography, clinically diagnosed with UAP in low or medium risk; - belong to Yang deficiency and blood stasis syndrome according to TCM, and give written informed consent. - For the diagnostic criteria of UAP, the investigators will refer to 2014 AHA/ACC Guidelines for the Diagnosis and Management of Non-ST-Elevation Acute Coronary Syndromes. - For the TCM diagnostic criteria, the investigators will refer to Guidelines for Clinical Research into New Traditional Chinese Medicine Drugs for Chest Obstruction (2002 edition). Exclusion Criteria: - chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia - with New York Heart Association class III or IV heart failure, in acute phase of cerebral infarction; - with uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg in the resting state) - with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia; - female patients in pregnancy or lactation; - by participating in other clinical trials. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences | National Natural Science Foundation of China, Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine |
Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000 Jan 10;160(1):25-37. Review. — View Citation
Jiang M, Zhang C, Zheng G, Guo H, Li L, Yang J, Lu C, Jia W, Lu A. Traditional chinese medicine zheng in the era of evidence-based medicine: a literature analysis. Evid Based Complement Alternat Med. 2012;2012:409568. doi: 10.1155/2012/409568. Epub 2012 J — View Citation
Niccoli G, Montone RA, Lanza GA, Crea F. Angina after percutaneous coronary intervention: The need for precision medicine. Int J Cardiol. 2017 Dec 1;248:14-19. doi: 10.1016/j.ijcard.2017.07.105. Epub 2017 Aug 12. Review. — View Citation
Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr;28(2):283-93. doi: 10.3122/jabfm.2015.02.140189. Review. — View Citation
Zhang HJ, Wang ZX. Yin-yang and Zheng: Exported from Chinese medicine. Chin J Integr Med. 2014 Apr;20(4):250-5. doi: 10.1007/s11655-014-1777-z. Epub 2014 Apr 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiovascular events | Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death. | Record the incidence of major adverse cardiovascular events in one year by follow-up. | |
Secondary | The thrombelastograph | Parameters assessed by were R (represent clotting time), K and Angle (reflect clot strength and development), MA (maximum platelet-fibrin clot strength), CI (represents overall coagulability), and LY30 (represents lysis). | Before treatment and at eight weeks after treatment. | |
Secondary | TCM symptom scale score | TCM syndrome scale includes items of chest tightness, chest pain, heavy body, obesity, phlegm, dark complexion, tongue condition and pulse condition. The chest tightness and chest pain, have 4-grade options of none, mild, moderate and severe, marked as 0, 2, 4 and 6 respectively. The other items have two options of yes or no, marked as 0 and 1 respectively. The higher scores mean more serious symptoms. | Before treatment, four and eight weeks after treatment. | |
Secondary | Seattle angina questionnaire | The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. Higher scores mean a better outcome. | Before treatment, four and eight weeks after treatment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Completed |
NCT05088291 -
Application of a New X-ray Protective Device in Coronary Interventional Therapy
|
||
Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
Not yet recruiting |
NCT04995159 -
Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System
|
N/A | |
Recruiting |
NCT02967718 -
Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome
|
N/A | |
Completed |
NCT02888652 -
Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
|
||
Terminated |
NCT02045134 -
Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery
|
N/A | |
Completed |
NCT02163044 -
The Hellenic Postprandial Lipemia Study (HPLS)
|
||
Active, not recruiting |
NCT02244853 -
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
|
N/A | |
Completed |
NCT02753829 -
Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease
|
N/A | |
Terminated |
NCT01906957 -
Cognition and Exercise Training
|
N/A | |
Completed |
NCT01920009 -
Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
|
N/A | |
Completed |
NCT01826552 -
Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent
|
Phase 4 | |
Completed |
NCT02440893 -
Understanding the Effect of Metformin on Corus CAD (or ASGES)
|
||
Recruiting |
NCT01689688 -
Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography
|
N/A | |
Completed |
NCT01779401 -
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
|
N/A | |
Recruiting |
NCT01456364 -
Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing
|
Phase 4 | |
Recruiting |
NCT01462799 -
COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care
|
N/A | |
Completed |
NCT01428947 -
Does Coronary Angiography Cause Cognitive Dysfunction?
|
N/A |