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A Randomized Controlled Trial and Omics Research on Shenzhu Guanxin Formula in managing Chronic Coronary Syndrome by Regulating Regulating Platelet NLRP3 Pathway for Anti-inflammatory Effects.

A Randomized Controlled Trial and Omics Research on Shenzhu Guanxin Formula in managing Chronic Coronary Syndrome by Regulating Regulating Platelet NLRP3 Pathway for Anti-inflammatory Effects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001539
Enrollment
Unknown
Registered
2026-06-20
Start date
2025-03-26
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic coronary syndromes

Interventions

Treatment group:Conventional Western medical therapy combined with Shenzhu Guanxin Formula.
Control group:Conventional Western medical therapy for chronic coronary syndrome (CCS).

Sponsors

The Eighth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Patients who meet the CCS and traditional Chinese medicine syndrome diagnostic criteria specified in this study. 2) Aged 40–85 years, regardless of gender. 3) Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with severe hepatic or renal impairment (AST, ALT > 3 times the upper limit of normal, TBIL > 2 times the upper limit of normal, eGFR < 30 mL/min), malignant tumors, heart failure, or other severe diseases affecting survival. 2) Patients with psychiatric or neurological disorders who are unable to cooperate. 3) Women who are pregnant, planning to become pregnant, or breastfeeding. 4) Patients with allergies to the investigational drug or any of its components. 5) Patients who have participated in other drug trials within the past month. 6) Other patients whom the investigator considers unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Exercise tolerance-related parameters;

Secondary

MeasureTime frame
Seattle Angina Questionnaire score;Inflammation-related markers;Platelet activation markers;Lipid- and glucose-related parameters;AI;Carotid and subclavian artery ultrasound examination;Electrocardiogram (ECG);Echocardiogram;New York Heart Association Functional Classification;Efficacy based on TCM syndrome scores;

Countries

China

Contacts

Public ContactXu Danping

The Eighth Affiliated Hospital of Sun Yat-sen University

xudanping@hotmail.com0755-83982222

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026