Skip to content

A Randomized Controlled Clinical Trial of Tongguan Capsule in Patients with Coronary Heart Disease and Chronic Inflammation

A Randomized Controlled Clinical Trial of Tongguan Capsule in Patients with Coronary Heart Disease and Chronic Inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000427
Enrollment
Unknown
Registered
2026-02-26
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Coronary Heart Disease

Interventions

Tongguan group:Tongguan
Tongguan+Colchicine group:Tongguan+Colchicine

Sponsors

Fangcun Hospital, Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 180 Years

Inclusion criteria

Inclusion criteria: (1) Aged =18 years, male or female. (2) Meeting the diagnostic criteria for residual inflammatory risk in chronic coronary syndrome (Western medicine diagnosis), and meeting the diagnostic criteria for Qi Deficiency and Blood Stasis with Phlegm-Turbidity Syndrome (Traditional Chinese Medicine diagnosis). (3) No use of antibiotics, steroids or other hormonal medications, or Chinese herbal preparations within the past month. (4) Voluntarily participating in this trial and providing signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe conditions including: severe heart failure (NYHA Class IV or left ventricular ejection fraction =30%), malignant arrhythmia, aortic dissection, circulatory failure, shock, tension pneumothorax, acute pulmonary embolism, respiratory failure, or other thoracic skin/tissue/chest wall pathologies. (2) Patients with concurrent infections originating from other systems, such as pneumonia, urinary tract infection, or gastrointestinal inflammation. (3) Patients with severe hepatic or renal impairment (ALT > 3 times the upper limit of normal and/or Scr = 265 µmol/L). (4) Patients with severe hematological diseases, neurological or psychiatric disorders, or malignant tumors. (5) Women who are pregnant, lactating, or planning for pregnancy. (6) Patients currently participating in other clinical trials. (7) Patients with a known allergy to the investigational drug(s).

Design outcomes

Primary

MeasureTime frame
High-sensitivity C-reactive protein;Neutrophil extracellular traps;Interleukin-6;Absolute neutrophil count and percentage;

Secondary

MeasureTime frame
ajor Adverse Cardiovascular Events;TCM Syndrome Score;Seattle Angina Questionnaire (SAQ) Score;

Countries

China

Contacts

Public ContactZhou Yuanshen

Fangcun Hospital, Guangdong Provincial Hospital of Chinese Medicine

yuanshenzhou@gzucm.edu.cn13580347116

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026