Cardiac neurosis (syndrome of deficiency of both qi and yin)
Conditions
Interventions
Control group:Placebo granules: Oral administration 5g/bag TID
Experimental group:Qidong Yixin Granules: Oral administration 5g/bag TID
Sponsors
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18-50 years gender not restricted; (2) Diagnosed with Qi-Yin deficiency syndrome; (3) Meets the criteria for cardiac neurosis according to the "Practical Internal Medicine" (16th edition) exhibiting significant cardiovascular symptoms such as palpitations chest pain and dyspnea; (4) Experiencing mild insomnia (PSQI 11-15 points) may be accompanied by mild anxiety (GAD-7 5-9 points) or depression (PHQ-9 5-9 points); (5) Physical examination and ambulatory electrocardiogram within one week prior to enrollment show no significant abnormalities; (6) Willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Exclude patients with organic heart diseases (such as coronary artery disease cardiomyopathy congenital heart disease valvular disease heart failure etc.): abnormal findings on cardiac CTA (stenosis >50%) positive treadmill exercise test or abnormal echocardiography within 3 months prior to enrollment; (2) Poor blood pressure control (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg after treatment) or requiring pharmacological intervention; (3) Poor lipid control or requiring pharmacological intervention; (4) Use of psychotropic medications antiarrhythmic drugs or psychotherapy within 1 week prior to enrollment; (5) Concomitant cerebrovascular disease or severe primary diseases of the liver kidney or hematopoietic system (ALT or AST more than twice the upper limit of normal or creatinine above the upper limit of normal; hemoglobin <90 g/L); (6) Concomitant hyperthyroidism pheochromocytoma or other severe endocrine or metabolic diseases; (7) Concomitant chronic obstructive pulmonary disease (COPD) asthma active tuberculosis bronchiectasis pulmonary embolism pulmonary heart disease or other severe respiratory diseases; (8) Gastrointestinal surgery or diseases that may affect absorption of the investigational drug acute or chronic pancreatitis severe primary hematologic or psychiatric disorders or any documented history of active or suspected malignancy within 1 year prior to screening or history of malignancy; (9) Pregnant currently breastfeeding or in the pre-pregnancy period; (10) Allergic constitution history of multiple drug or food allergies or known allergy to any component of the investigational drug; (11) Patients unable to exercise judged by the investigator as possibly affecting exercise capacity unable to perform activities of daily living independently or unable to take oral medication; (12) Use of Chinese herbal medicines with similar therapeutic effects within the past 7 days (e.g. herbal decoctions patent Chinese medicines herbal injections); (13) Receiving any investigational treatment other than the study drug; (14) Suspected or confirmed history of alcohol or drug abuse; (15) Subjects unable to understand or complete the required questionnaires due to language visual intellectual impairments or other reasons; (16) Inability to comply with the follow-up schedule of the study assessments or deemed unsuitable for participation by the investigators clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| According to the TCM syndrome quantitative scoring table (referencing the "Cardiac Neurosis (TCM Diagnostic and Therapeutic Protocol for Cardiac Neurosis)" issued by the Office of the State Administration of Traditional Chinese Medicine Trial Version) evaluate the overall clinical efficacy rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in anxiety status assessed by the Generalized Anxiety Disorder Scale (GAD-7) from baseline;Assessing changes in depressive status from baseline using the Patient Health Questionnaire-9 (PHQ-9);Evaluate symptom improvement according to the Self-Rating Scale for Somatic Symptoms (SSS);Changes in the Total Score of the TCM Syndrome Quantitative Evaluation Scale;Analyze the changes in heart rate variability based on 24-hour dynamic electrocardiogram;Assessing changes in sleep quality from baseline using the Pittsburgh Sleep Quality Index (PSQI); | — |
Countries
China
Contacts
Public ContactMingjun Zhu Peng Chen
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed