ABSTRACT
BACKGROUND: Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA. METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial. DISCUSSION: We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100044563 . Registered on 24 March 2020.
Subject(s)
Angina, Stable , Drugs, Chinese Herbal , Angina, Stable/diagnosis , Angina, Stable/drug therapy , China , Double-Blind Method , Drugs, Chinese Herbal/adverse effects , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
BACKGROUND: Coronary microvascular disease (CMVD) can be described as one of the cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculatory lesions, often presenting as angina pectoris attacks. Coronary artery microtubular dysfunction is one of the pathogenic features of coronary heart disease, but its occurrence and development and the current CMVD-intervention therapy needs further research. Chinese traditional medicine (TCM) has advantages for the treatment of cardiovascular diseases. Hence, this article describes an ongoing randomized controlled clinical trial based on the theory of TCM for the purpose of evaluating the efficacy and safety of Guhong injection versus placebo in patients with CMVD. METHODS/DESIGN: This is a multicenter, randomized, parallel-arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, and with an 8-week follow-up. The primary outcome is therapeutic efficacy. Secondary outcomes include the quantitative score of TCM syndromes (a series of TCM symptoms and signs of coronary heart disease), the average frequency of anginal attacks, electrocardiogram (ECG) changes, inflammatory response, endothelial function indicators and myocardial metabolites. DISCUSSION: This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results should provide high-quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD. TRIAL REGISTRATION: Chinese Clinical Trials Registry, ID: ChiCTR1900022902. Registered on 27 April 2019.
Subject(s)
Anti-Inflammatory Agents/administration & dosage , Coronary Artery Disease/drug therapy , Glutamine/analogs & derivatives , Plant Extracts/administration & dosage , Adult , Aged , Anti-Inflammatory Agents/adverse effects , China , Coronary Artery Disease/diagnostic imaging , Double-Blind Method , Female , Glutamine/administration & dosage , Glutamine/adverse effects , Humans , Injections , Male , Middle Aged , Multicenter Studies as Topic , Plant Extracts/adverse effects , Prospective Studies , Randomized Controlled Trials as Topic , Time Factors , Treatment OutcomeABSTRACT
@#Objective To explore the effect of early swallowing function training in the prevention of stroke-associated pneumonia(SAP). Methods 78 patients with stroke and swallow dysfunction were divided into training group (n=39) and control group (n=39). All patientswere given routine nursing care, while the training group received early swallowing function training additionally. Clinical data of thetwo groups were compared. Results The incidence of SAP in the training group (25.6%) was lower than the control group (46.2%) (χ2=3.57,P<0.05)。Conclusion Early swallowing function training is effective to prevent stroke-associated pneumonia.
