stable coropary heart disease with anxiety state
Conditions
Interventions
Experimental group:Basic treatment combined with Shuangxinning
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for stable coronary artery disease (SCAD) outlined in the 2018 Chinese Medical Association Cardiovascular Disease Branch Guidelines for Diagnosis and Treatment of Stable Coronary Heart Disease; (2) Patients meeting the diagnostic criteria for anxiety state as outlined in the 2016 Chinese Medical Association Expert Consensus on Diagnosis and Treatment of Anxiety, Depression, and Somatization Symptoms in General Hospitals and the 2019 Chinese Association of Traditional Chinese Medicine Expert Consensus on Preventive Treatment of Anxiety State in Traditional Chinese Medicine; (3) Patients with a Hamilton Anxiety Rating Scale (HAMA-14) total score between 7 and 28; (4) Meet the pattern differentiation criteria for Qi Stagnation and Blood Stasis or Heat Disturbing the Mind in the 2021 National Standard for Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine (Syndrome Section); (5) Stable vital signs and adequate communication ability; (6) Aged 18–75 years, no gender restriction; (7) No use of other Chinese herbal medicines or proprietary Chinese medicines for anxiety relief or stable coronary heart disease within the past two weeks; (8) Voluntary/informed consent to participate in this trial, agreement to undergo collection of TCM diagnostic information (tongue coating, facial examination, etc.), and signed informed consent form. Patients meeting all of the above inclusion criteria may be enrolled.
Exclusion criteria
Exclusion criteria: (1) Patients at high risk of suicide; (2) Patients with a Hamilton Depression Rating Scale (HAMD-17) total score =17 during screening/baseline; (3) Patients with a history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorders, factitious disorders, or somatoform disorders; patients with severe personality disorders, particularly antisocial, borderline, or histrionic personality disorders, where the investigator judges compliance with the study protocol to be compromised; (4) Patients meeting diagnostic criteria for stable coronary artery disease but refusing treatment according to the 2018 Diagnosis and Treatment Guidelines for Stable Coronary Artery Disease; (5) Patients with alcohol or substance abuse or dependence within 6 months prior to screening; Patients with severe or unstable clinically significant medical conditions, including any neoplastic, renal, respiratory, endocrine (including thyroid dysfunction), gastrointestinal, hematologic (e.g., bleeding tendency), or neurological disorders; (6) History of epileptic seizures or any other condition potentially triggering seizures: (7) Undergone psychosurgical procedures, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) within 3 months prior to screening; (8) Patients with severe arrhythmias such as second-degree type II AV block, third-degree AV block, sick sinus syndrome, as well as severe hypotension, hypertensive emergencies, uncontrolled severe heart failure (NYHA Class III or higher), aortic stenosis, aortic dissection, acute pericarditis or cardiac tamponade, acute pulmonary edema, acute myocarditis; (9) Patients with severe hepatic or renal impairment (ALT or AST exceeding twice the upper limit of normal, BUN or Cr exceeding 1.2 times the upper limit of normal), progressive diseases, or conditions with poor prognosis such as severe infection, severe electrolyte imbalance, or acid-base disturbance; (10) Individuals with allergic constitutions or a history of allergy to traditional Chinese medicine or at least two medications; (11) Patients who have previously received adequate and full-course treatment with two or more anxiolytic drugs and/or Class II drugs (i.e., clinically appropriate doses for at least 4 weeks) without improvement; (12) Patients who have undergone systemic psychotherapy or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or phototherapy) within 6 weeks prior to baseline visit; (13) Breastfeeding or pregnant women, or individuals (including males) with a desire to conceive during the trial period; Patients unable to use safe and effective contraceptive measures; (14) Inability to take medication as prescribed; (15) Participation in other drug clinical trials within 3 months prior to screening; (16) Other conditions deemed unsuitable for enrollment by the investigator. Exclusion will occur if any of the above criteria are met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale-14 Score;Seattleanginaquestionnaire Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Generalized anxiety disorder-7 Score;Pittsburgh sleep quality index ;Resting Electrocardiogram;Traditional Chinese Medicine Syndrome Scores;Major cardiovascular adverse events; | — |
Countries
China
Contacts
Public ContactHaibin Zhao
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed