An Adaptive Enrichment Designed, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anshen Buxin Liuwei Pills in the Treatment of Cardiac Neurosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine
研究概览
简要总结
This study aims to assess the effect and safety of the traditional Mongolian medicine Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis.
详细描述
Cardiac neurosis is a group of symptoms characterized by the coexistence of cardiovascular disease related symptoms and nervous system disorders. Anshen Buxin Liuwei Pill is a kind of traditional Mongolian medicine for the treatment of cardiac neurosis. This study aims to evaluate the effect and safety of Anshen Buxin Liuwei Pill for cardiac neurosis in a prospective, randomized, double-blind, placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, ≤75 years old;
- •Meet the diagnostic criteria for cardiac neurosis: the patient has palpitations, precordial pain, chest tightness, shortness of breath, dyspnea, dizziness, insomnia and dreaminess, cold hands and feet, hyperhidrosis and other cardiovascular symptoms and neurological disorders;
- •Meet the diagnostic criteria of Heyisheng type palpitations in Mongolian medicine;
- •There is no objective diagnosis of coronary heart disease (in accordance with any of the following): ①The activity flat test is negative; ② Coronary angiography or coronary CTA suggests that the lumen stenosis is ≤50%; ③ Exercise or drug load radionuclide examination results suggest no myocardial ischemia;
- •The patient did not take anti-anxiety and depression drugs or psychotropic drugs within 2 weeks before enrollment;
- •agrees to voluntarily participate in the study and signs an informed consent form .
排除标准
- •Accompanied by organic heart disease, severe cardiopulmonary insufficiency;
- •Poor hypertension control (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after treatment);
- •Those with malignant arrhythmia;
- •Those who use pacemakers;
- •Patients with hyperthyroidism;
- •Combined with severe liver and kidney damage (ALT, AST or TBIL> 2 times the upper limit of the normal reference value, or Cr> 1.5 times the upper limit of the normal reference value);
- •People with serious primary diseases such as hematopoietic system or mental illness;
- •Accompanying any other serious diseases or conditions such as malignant tumors;
- •Women during pregnancy and lactation;
- •People with allergies or allergies to the known ingredients of the research drug;
- •Participated in other clinical research in the past 3 months;
- •According to the judgment of the investigator, the subject is not suitable for research observation.
研究组 & 干预措施
Anshen Buxin Liuwei Pills
15 pills/time, 2 times/day, orally，for 8 weeks
干预措施: Anshen Buxin Liuwei Pill (Drug)
Placebo
15 pills/time, 2 times/day, orally. for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine
时间窗: 8 weeks
The scale is to record the symptoms of palpitation with Heyisheng Type in Mongolian Medicine, which is also usually seen in cardiac neurosis. This scale includes two domain: the primary symptoms and the secondary symptoms. The domain of the primary symptoms includes palpitations, chest tightness, chest pain, insomnia, and restlessness using the evaluating 4-Grade scales (Normal:0; Mild:3; Moderate:6 and Severe:9), while the domain of the secondary symptoms includes dizziness, like to sigh, easy to startle, tinnitus, blurred vision, fatigue, sweating, irritability, using the evaluating 4-Grade scales (Normal:0; Mild:1; Moderate:2 and Severe:3).
次要结局
- Cardiac Neurosis Symptom Self-rating Scale(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.)
- hypersensitive C-reactive protein (hs-CRP)(Baseline, 4 weeks, 8 weeks)
- Cardiac autonomic nervous function(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.)
- Self-rating depression scale (SDS)(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.)
- Self-rating Anxiety Scale (SAS)(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.)
- The level of serotonin(Baseline, 4 weeks, 8 weeks)
- Pittsburgh Sleep Scale Score(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.)
- Consumption of estazolam(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences