ITMCTR2100004585招募中4 期
Adaptive enrichment, multicentre, randomized, double-blind, placebo-controlled clinical trial of Anshen Buxin Liuwei Pill in the treatment of cardiac neurosis (Heyisheng type palpitation)
Fuwai Hospital, Chinese Academy of Medical Sciences0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1. Aged >= 18 and <=75 years;
- •2. It meets the diagnostic criteria of cardiac neurosis: the patient has heart palpitations, precardiac pain, chest shortness of breath, dyspnea, dizziness, insomnia and dreaminess, hand and foot chills, sweating and other cardiovascular symptoms and neurological disorders;
- •3. It meets the diagnostic criteria of Mongolian medicine Heyisheng type palpitation;
- •4. No objective basis for the diagnosis of CHD (conforms to any of the following);
- •(1) The movable plate test was negative;
- •(2) Coronary angiography or coronary CTA indicated lumen stenosis <= 50%;
- •(3) No myocardial ischemia was found by exercise or drug stress radionuclide examination.
- •5. Patients did not take anti-anxiety and depression drugs or psychotropic drugs within 2 weeks before enrollment;
- •6. Signed the informed consent.
排除标准
- •(1) Patients with organic heart disease and severe cardiopulmonary insufficiency;
- •(2) Poor hypertension control (post-treatment systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg);
- •(3) Patients with malignant arrhythmia;
- •(4) Patients with cardiac pacemakers;
- •(5) Patients with hyperthyroidism;
- •(6) Severe hepatic and renal function impairment (ALT, AST or TBIL>2 times the upper normal reference value, or CR BBB>5 times the upper normal reference value);
- •(7) Complicated with hematopoietic system and other serious primary diseases, mental illness;
- •(8) SAS >= 70 points;
- •(9) SDS >= 73 points;
- •(10) Accompanied by any other serious disease or condition such as: malignant tumor;
- •(11) Women in pregnancy or lactating period;
- •(12) People with allergies or allergies to known ingredients of the study drug;
- •(13) Participated in other clinical researchers within the last 3 months;
- •(14) In the Investigator's judgment, the subjects were unsuitable for study observation.
研究者
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