Abstract
Background
SAP (Stable Angina Pectoris, SAP) is a clinical syndrome characterized by acute and temporary myocardial ischemia and hypoxia due to an increase in the myocardial load resulting from a fixed severe stenosis of the coronary artery. Its’ characteristics include paroxysmal pressure pain or tightness in the prothorax, primarily retrosternal pain, which can radiate to the precordium and upper left ulna. It often occurs during physical exertion and lasts for several minutes. Traditional Chinese Medicine (TCM) has unique advantages in treating this disease due to holistic, dynamic and dialectical system of thought regarding life and diseases. Clinical efficacy is the basis for the survival and development of Traditional Chinese Medicine. Scientifically evaluating the clinical efficacy of such TCM treatments is of great importance for promoting its’ modernization and internationalization. In this study, we aimed to observe the therapeutic effects of Compound Salvia Droplet Pills on patients with SAP (Qi deficiency and blood stasis), as shown by a standardized clinical study on the treatment of SAP by means of supplementing qi and activating blood circulation by taking TCM treatments for CHD, thereby providing a practical and valuable clinical treatment approach.
Methods
A randomized, controlled trial was designed to evaluate the efficacy and safety of Compound Salvia Droplet Pills for the treatment of SAP.
A proposed total of 60 patients with SAP (Qi deficiency and blood stasis type) are to be entered into the study.
The patients shall be randomly assigned to treatment groups (compound Salvia Droplet Pills, 10 pills/time, 3 times a day, + aspirin enteric - coated tablets 100mg/time, once a day) or the control group (compound Salvia Droplet Pills mimetics, 10 pills/time, 3 times a day, + aspirin enteric - coated tablets 100mg/time, once a day), duration of 28 ±1, and follow-up for 14 ± 3 days.
Primary outcome measures: angina pectoris symptom scores and TCM syndrome scores.
Secondary outcome measures: ECG, incidence and mortality of cardiovascular events, etc.
Discussion
This is a randomized controlled trial for Compound Salvia Droplet Pills to treat SAP on the basis of conventional therapy, to preliminarily evaluate the efficacy in the treatment of patients with SAP (angina symptoms, signs and reducing the use of vasodilator drugs, etc.), and follows up on the short -term prognosis of patients to provide clinical evidence for the use of compound Salvia Droplet Pills in patients with SAP.
The effect of Danshen extract on lipoprotein-associated phospholipase A2 levels in patients with stable angina pectoris: study protocol for a randomized controlled trial - the DOLPHIN study
