Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the effect and safety of the traditional Mongolian medicine Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Beijing University of Chinese Medicine; Ministry of Science and Technology of the People's Republic of China

Criteria

Inclusion Criteria:

• 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 .

Exclusion Criteria:

• 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;

• SAS≥70;

• SDS≥73;

• 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.