Clinical Evaluation and Effect Mechanism Study of TCM Program Intervention in High-risk Groups with Residual Risk of TG and HDL-C/ HS-CRP after PCI based on the Theory of ''Tan Yu Fu Xie, Yun Jie Cheng Du''

Efficacy Evaluation and Effect Pathway Study of Huotan Jiedu Tongluo Decoction in High-risk Population with Residual Risk Dyslipidemia and/or Inflammatory Reaction after PCI

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064813

Enrollment

Unknown

Registered

2022-10-19

Start date

2022-11-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

None listed

Interventions

Experimental group:Western medicine standardized treatment + Huotan Jiedu Tongluo granules

Control group:Western medicine standardized treatment + placebo simulation granules

Eligibility

Sex/Gender

All

Age

30 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Aged range from 30 to 79 years, no gender limit; 2. 15 to 180 days after PCI (including PTCA), the patient was diagnosed with coronary heart disease by imaging; 3. TCM syndrome differentiation is phlegm and blood stasis syndrome; 4. Triglyceride (TG) > 2.26mmol/L(200mg/dl) and high density lipoprotein cholesterol (HDL-C) 2 mg/L; 7. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, and stroke with unknown type) or symptomatic lower extremity artery disease in the last 6 months; 2. Uncontrolled grade 3 hypertension (>=180/110mmHg) or hypotension (=2 times the upper limit of clinical reference value), other serious primary diseases or mental diseases that affect life span and malignant tumors; 7. Severely allergic, known or likely to be allergic to the test drug or its components; 8. The researchers considered that there were clinical conditions that were not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Triglyceride;High density lipoprotein-C;Hypersensitivity C-reactive protein;	—

Secondary

Measure	Time frame
Low density lipoprotein-C;	—

Countries

China

Contacts

Public ContactDeng Yue

The Affiliated Hospital of Changchun University of Chinese Medicine

dyue7138@sina.com+86 15948800776

Outcome results