Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina
| العنوان: | Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina |
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| المؤلفون: | Lei Shi, Kai Wang, Yang Wu, Lei-Lei Liu, Yu Wang, Jun-Jun Cai, Xian Wang |
| المصدر: | Medicine |
| بيانات النشر: | Ovid Technologies (Wolters Kluwer Health), 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | unstable angina, Adult, Male, medicine.medical_specialty, Acute coronary syndrome, Adolescent, Administration, Oral, Placebo, Luofengning granule, law.invention, Angina, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Study Protocol Clinical Trial, law, Internal medicine, medicine, Clinical endpoint, Humans, Angina, Unstable, 030212 general & internal medicine, Myocardial infarction, Aged, Aged, 80 and over, business.industry, Unstable angina, General Medicine, Middle Aged, medicine.disease, 030220 oncology & carcinogenesis, Heart failure, randomized controlled trial, Female, Chinese herbal medicine, business, Research Article, Drugs, Chinese Herbal |
| الوصف: | Introduction: Although the current western treatment plans for unstable angina (UA) has been optimized in past decades, UA still is a common phenotype of acute coronary syndrome and significantly influence the quality of life and endanger lives. In China, the clinical application of Chinese herb medicine is considered as an effective approach to treating UA and widely recognized by patients. In clinical practices, we found Luofengning granule (LFN-G) could improve clinical manifestations of patients with UA, but there is lack of rigorous proof of evidence-based medicine. This trial aims to further evaluate the efficacy of LFN-G in the treatment of UA. Methods: A prospective, open-label, randomized, placebo-controlled clinical will be performed. A total of 60 patients diagnosed with UA will be randomly allocated to either the treatment group or the control group with a 1:1 ratio. The participants in the treatment group will receive LFN-G treatment and the participants in the control group will receive placebo. Meanwhile, both groups continue to undergo standard western medicine treatments. The duration of interventions is 4 weeks. The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death. Secondary outcomes include Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4). In addition, some biochemical indexes of blood and hematological indexes will be used to assess the safety of treatments. Any adverse effects of the treatment will be recorded. Discussion: The results of this trial will provide compelling evidence of the efficacy and safety of LFN-G for treatment of UA and preliminarily reveal the potential mechanism of how LFN-G acts. Finally, it will widen treatment options for patients with UA. |
| تدمد: | 1536-5964 0025-7974 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::801b931e584f3c944115d0fa1c273148Test https://doi.org/10.1097/md.0000000000020025Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....801b931e584f3c944115d0fa1c273148 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15365964 00257974 |
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