Clinical study of Huangjin Shuangshen Granules in treating patients with anxiety and depression after coronary stent implantatio

Phase 1

• Conditions: Anxiety and depression after coronary stent implantation

• Registration Number: ITMCTR2000003774
• Lead Sponsor: Guang'anmen 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) After percutaneous coronary stent implantation and conventional Western medical treatment;
2) TCM syndrome differentiation is the mutual syndrome of stasis, poison and stagnation;
3) 18-75 years old, gender is not limited;
4) Heart function classification <= NYHA II Grade and echocardiographic ejection fraction 45%;
5) Subjects must give informed consent to this trial and sign an informed consent form before the trial.

Exclusion Criteria

1) Stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) within the past 6 months;
2) Poorly controlled hypertension (>=180/100mmHg) or hypotension (<90/60mmHg);
3) Combined malignant arrhythmia (ventricular tachycardia, rapid atrial fibrillation, atrial flutter, atrioventricular block above II degree II, complete bundle branch block) recently repeated to the author;
4) Complicated with severe liver and kidney dysfunction (creatinine clearance <= 40ml/min, serum transaminase >= 2 x upper limit of clinical reference value), other serious primary diseases, tumors or mental diseases that affect life span;
5) Pregnancy, planned pregnancy or lactation Women;
6) Known bleeding tendency or bleeding disease, or uncontrollable coagulation mechanism disorder, or active bleeding and invasive examination and treatment operations within 2 weeks, or history of severe trauma or major surgery within 12 weeks;
7) Those who are participating in other clinical trials;
8) Those who are allergic to the experimental drugs and their constituents;
9) The current or past history of drug abuse or drug use;
10) Suffering from dementia or severe mental disorders that make it unable to understand or express knowledge Those who agree;
11) Those who are drug or alcohol dependent, or other situations where the researcher thinks it is inappropriate to participate in this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The incidence of major cardiovascular and cerebrovascular adverse events;

Secondary Outcome Measures

Name	Time	Method
Blood lipids;TCM syndrome score;Seattle Angina Questionnaire, SAQ;Hamilton Depression Scale (HAMD-24);Pittsburgh Sleep Quality Scale;Hamilton Anxiety Scale (HAMA-14);