Clinical trial NCT04932395: Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis
Official title: An Adaptive Enrichment Designed, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anshen Buxin Liuwei Pills in the Treatment of Cardiac Neurosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Neurosis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
name: Beijing University of Chinese Medicine
First posted: 2021-06-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Palpitation with Heyisheng Type Symptoms Scale in Mongolian Medicine
timeFrame: 8 weeks
Secondary outcomes:
measure: Cardiac autonomic nervous function
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
measure: Cardiac Neurosis Symptom Self-rating Scale
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
measure: Self-rating depression scale (SDS)
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
measure: Self-rating Anxiety Scale (SAS)
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
measure: Pittsburgh Sleep Scale Score
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
measure: Consumption of estazolam
timeFrame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks.
measure: hypersensitive C-reactive protein (hs-CRP)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: The level of serotonin
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Xinxiang
country: China
facility: The Third Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Hohhot
country: China
facility: Inner Mongolia International Mongolian Hospital
state: Inner Mongolia
city: Kunshan
country: China
facility: Kunshan First People's Hospital
state: Jiangsu
city: Jinan
country: China
facility: The Second Affiliated Hospital of Shandong University of Chinese Medicine
state: Shandong
Study officials:
References: