Clinical Efficacy Study of Tiaogan Yiqi Dingji Formula on Tachyarrhythmia Based on Psycho-Cardiology

Phase 1

Recruiting

• Conditions: tachyarrhythmia

• Registration Number: ITMCTR2100004802
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of western medicine for tachyarrhythmia.
2. Meet the diagnostic criteria for depression and anxiety.
3. Hamilton Depression Scale (HAMD) 17 items score 7-24 points (not including 24 points) or (and) Hamilton Anxiety Scale (HAMA) 14 items score 7-21 points (not including 21 points).
4. Comply with TCM diagnostic criteria for heart palpitations (stagnation of liver and qi, syndrome of heart deficiency and timidity).
5. Aged 18-85 years.
6. There is no restriction on gender.
7. Subjects were informed and signed an informed consent form voluntarily.

Exclusion Criteria

1. Transient tachyarrhythmia caused by tobacco, alcohol, coffee, fatigue, infection, fever, anemia, drug-induced electrolyte disturbance (such as low potassium), etc.
2. It is hereditary arrhythmia, tachyarrhythmia combined with severe angina pectoris, premature ventricular contractions with a short combined rhythm interval of <300 ms, supraventricular tachycardia with an attack lasting more than 24 hours, new onset atrial flutter, first-diagnosed atrial fibrillation, Pre-excitation combined with atrial fibrillation is accompanied by rapid ventricular rate, continuous ventricular tachycardia (the duration of ventricular tachycardia >= 30s), torsade de pointes type ventricular tachycardia, etc.
3. Patients who have non-drug anti-arrhythmic indications such as catheter ablation, electrical cardioversion, and willingness to operate.
4. Patients with pacemaker implantation or perioperative period.
5. Acute myocardial infarction, severe cardiac insufficiency (NYHA cardiac function class III, IV or LVEF<40%).
6. Patients who have taken sedative, hypnotic, anti-anxiety, and antidepressant drugs in the 4 weeks before the trial.
7. Suicidal attempts or suicidal tendencies (HMD item 3 score >= 2 points).
8. Patients with obvious hemodynamic disorders, syncope, hypotension, and shock.
9. Severe mental disorders or other reasons unable to cooperate.
10. Patients with severe liver, kidney, hematopoietic system and other primary diseases and dysfunctions.
11. Women who are pregnant, preparing to become pregnant or breast-feeding.
12. Patients who have participated in other clinical trials in the past 3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Holter;Frequency and duration of tachyarrhythmia;

Secondary Outcome Measures

Name	Time	Method
Summary health status survey (SF-36) quality of life score;Depression/anxiety score;Therapeutic effect of TCM syndromes;