Skip to content

Clinical Study Protocol on the Use of Lipid-lowering Soft Pulse Pills to Reduce Residual Cholesterol Risk in Patients with Chronic Coronary Syndrome

Jiangzhi Ruanmaì Tablets Reduce Residual Cholesterol Risk in Chronic Coronary Syndrome: A Randomized Controlled Trial (RCT)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002544
Enrollment
Unknown
Registered
2025-12-27
Start date
2025-08-28
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Chronic coronary syndrome

Interventions

Treatment group:Control group: Chronic coronary syndromes: Refer to the "2024 ESC Guidelines for the Management of Chronic Coronary Syndromes," and administer routine antiplatelet, anticoagulant, lipi
Treatment group:Treatment group: On the basis of the control group's treatment, lipid-lowering soft pulse tablets (I) were additionally administered (orally, 8 tablets per dose, three times daily).

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the Western diagnostic criteria for chronic coronary syndrome; 2. There is currently no universally recognized authoritative standard for residual cholesterol risk in chronic coronary syndrome; previous studies have suggested that intervention should be considered for individuals with residual cholesterol levels =0.6 mmol/L in the population with atherosclerotic heart disease [1]; 3. The condition is diagnosed as spleen and kidney deficiency syndrome in traditional Chinese medicine; 4. Age between 18 and 80 years, with no restrictions on gender; 5. Patients who have given informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, brain, liver, or kidney diseases; valvular atrial fibrillation; tumors; hematological disorders; autoimmune diseases; metabolic diseases; severe infections; or severe arrhythmias. 2. Patients with abnormal liver or kidney function. 3. Pregnant women, those planning to become pregnant, or breastfeeding women. 4. Patients allergic to the drugs used in this study or with contraindications to the study medications. 5. Patients with anxiety, depression, cardiac neurosis, or other mental disorders/cognitive impairments. 6. Patients requiring elective or immediate surgery due to recent severe trauma. 7. Patients who have participated in other clinical trials within the past month. 8. Patients deemed unable to complete the study or adhere to follow-up by the investigator.

Design outcomes

Primary

MeasureTime frame
Residual Cholesterol;

Secondary

MeasureTime frame
Blood lipid evaluation indicators: Total Cholesterol, Triglycerides, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol, Apolipoprotein B, Lipoprotein(a).;Residual inflammation assessment indicators: high-sensitivity C-reactive protein, C-reactive protein, lymphocyte count, monocyte count, neutrophil count, neutrophil-to-lymphocyte ratio (Neutrophil/Lymphocyte), inflammation burden index (C-reactive protein × neutrophil-to-lymphocyte ratio), neutrophil-to-high-density lipoprotein cholesterol ratio (Neutrophil count/High-density lipoprotein cholesterol), systemic inflammation response index (Monocyte × Neutrophil).;Seattle Angina Questionnaire;Traditional Chinese Medicine Syndrome Score Scale;

Countries

China

Contacts

Public ContactFan Lu

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

F15661371932@163.com15661371932

Outcome results

None listed

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