Adaptive enrichment, multicentre, randomized, double-blind, placebo-controlled clinical trial of Anshen Buxin Liuwei Pill in the treatment of cardiac neurosis (Heyisheng type palpitation)
- Conditions
- Cardiac neurosis (Hessian palpitations)
- Registration Number
- ITMCTR2100004585
- Lead Sponsor
- Fuwai Hospital, Chinese Academy of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At week 8, the proportion of patients with Heyshin type palpitation symptoms improved in Mongolian medicine;
- Secondary Outcome Measures
Name Time Method SAS;Pittsburgh Sleep Scale score;Poor standing heart rate;serotonin;The frequency and dosage of the sedative and hypnotic drug serazepam;hs-crp;Incidence of adverse drug events and serious adverse events;SDS;Scores of the Evaluation Scale for the Symptom Classification of Heart Palpitations in Mongolian Medicine;Self-Rating Cardiac Neurosis Symptoms Scale ;