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Clinical study on the treatment of coronary heart disease with Guanxinning Tablet by regulating intestinal flora

Clinical study on the treatment of coronary heart disease with Guanxinning Tablet by regulating intestinal flora

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097864
Enrollment
Unknown
Registered
2025-02-26
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Coronary heart disease

Interventions

Conventional treatment group:Western medicine basic treatment for secondary prevention of coronary heart disease
Test group:Take Guanxinning tablets orally

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in clinical trials, sign informed consent forms, and follow the research process; 2. The age range is between 18 and 75 years old, including both genders; 3. Diagnosed as a patient with coronary heart disease.

Exclusion criteria

Exclusion criteria: 1. Occurred within 3 months: acute coronary syndrome, stroke, transient ischemic attack; cardiac or other macrovascular surgery; Percutaneous coronary intervention (PCI) or or coronary artery bypass grafting and other cardiac procedures; 2. Major surgery within 6 months prior to randomization; 3. Patients with active ulcers and abnormal coagulation function (hemoglobin less than 100g/L, platelet count less than 100×10^9/L or leukocyte =180mmHg and/or diastolic blood pressure >=110mmHg at two independent examinations prior to randomization; 8. Positive urine pregnancy test or lactating women; 9. Patients with allergies: such as patients who are known to be allergic to the study drug (including its components); 10. Those who are considered unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
16S sequencing of gut microbiota;

Secondary

MeasureTime frame
Blood routine testing;TCM syndrome;C-reactive protein;Low-density lipoprotein cholesterol, LDL-C;High-density lipoprotein cholesterol, HDL-C;Cholesterol;Triglyceride;Homocysteine;Glutamic-pyruvic transaminase;Glutamic oxaloacetic transaminase;Urea nitrogen;Apoli popro tein A1,ApoA1;Apoli popro tein B,ApoB;a - Lipoprotein(a), Lp(a);Free Fatty Acids, FFA;Thromboxane,TXB2 ;6-keto-PGF1a;NO;Superoxide Dismutase, SOD;Malondialdehyde, MDA;Soluble CD40 Ligand, sCD40L;Matrix Metalloproteinase-9, MMP - 9; Alkaline Phosphatase, ALP;Gamma-glutamyltransferase, GGT;Total Serum Bilirubin, TBIL;Direct Bilirubin, DBil;Creatinine;IL-6;Activated Partial Thromboplastin Time, APTT;Prothrombin Time, PT;International Normalized Ratio, INR;Thrombin Time, TT;Fibrinogen, FIB;Routine urine test;Stool routine examination;Human Chorionic Gonadotropin, HCG;Electrocardiogram;Creatine kinase,CM;sCD40L;MMP-9;IL-6;Cardiovascular event rate;Waist circumference;Waist to hip ratio;BMI;Ankle brachial index;

Countries

China

Contacts

Public ContactYu Huang

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

hy204308@163.com+86 138 1672 0338

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026