Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT04932395
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04932395
Study Brief:
Protocol Section:
NCT04932395