Skip to content

An Observational Study on the Treatment of Mild to Moderate Anxiety and Depression in Patients with Coronary Heart Disease after PCI Based on the "Double Heart" Model with Guanxin Ning Tablets

An Observational Study on the Treatment of Mild to Moderate Anxiety and Depression in Patients with Coronary Heart Disease after PCI Based on the "Double Heart" Model with Guanxin Ning Tablets

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000373
Enrollment
Unknown
Registered
2026-02-13
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate anxiety and depression in patients with coronary heart disease after PCI surgery

Interventions

control group:Standardized drug treatment after percutaneous coronary intervention (PCI) for coronary heart disease
experimental group:On the basis of standardized drug treatment after PCI for coronary heart disease, add Guanxinling Tablets

Sponsors

Zhengda Qingchunbao Pharmaceutical Co., LTD
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) It meets the indications for percutaneous coronary intervention in patients with coronary heart disease recommended by the "Chinese Guidelines for Percutaneous Coronary Intervention (2016)"; 2) It complies with the diagnostic criteria of chest pain with blood stasis syndrome combined with depression syndrome as stipulated in "Clinical Guidance Principles for New Chinese Medicines", with main symptoms: chest pain, chest tightness, depression or restlessness of mood; secondary symptoms: palpitations, shortness of breath, chest and rib pain, prone to sighing, sweating, insomnia, dark complexion, etc. The tongue appears pale purple, dark purple or with petechiae and ecchymosis, and the sublingual blood vessels are tortuous. The pulse is (thready and tense) and (deep and fine). One of the main symptoms and two or more of the secondary symptoms (including the main symptoms) are necessary for a diagnosis; 3) Mild to moderate anxiety or depression state, with a score of 5-14 points for either GAD-7 or PHQ-9; 4) Age ranging from 18 years to 80 years; 5) Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients whose mental symptoms are uncontrollable and who cannot cooperate; 2) Patients with severe cardiovascular diseases such as severe heart failure, cardiogenic shock, and malignant arrhythmia; 3) Patients with serious blood system, nervous system diseases and malignant tumors; patients with severe functional disorders of organs such as liver, kidney, lung and brain (with blood AST, ALT, Cr, BUN exceeding the upper limit of the reference value by 3 times); 4) Uncontrolled hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg); 5) Patients with active bleeding; 6) Pregnant women or lactating women; 7) Patients allergic to the drugs used in this study; 8) Patients who have participated in other clinical trials within the past 1 month.

Design outcomes

Primary

MeasureTime frame
Total score of TCM blood stasis syndrome and therapeutic effect of TCM blood stasis syndrome; ;Seattle Angina Questionnaire (SAQ) score; ;Generalized Anxiety Disorder Scale (GAD-7) score; ;Depression Symptom Screening Scale (PHQ-9) score; ; Cardiac ultrasound parameters, including left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF),;

Countries

China

Contacts

Public ContactXiaohua Dai

Anhui Provincial Hospital of Traditional Chinese Medicine

xin_d3980@163.com13856026266

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026