Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 4

Conditions: Cardiac Neurosis

Treatments: Drug: Placebo; Drug: Anshen Buxin Liuwei Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT04932395

ASBXLWW V2.0

Details and patient eligibility

About

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

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Anshen Buxin Liuwei Pills

Experimental group

Description:

15 pills/time, 2 times/day, orally，for 8 weeks

Treatment:

Drug: Anshen Buxin Liuwei Pill

Placebo

Placebo Comparator group

Description:

15 pills/time, 2 times/day, orally. for 8 weeks

Treatment:

Drug: Placebo