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A multicenter, randomized, double-blind, placebo-controlled parallel controlled clinical study on the treatment of stable coronary artery disease with Renshen Jianxin Capsules due to Qi deficiency and blood stasis syndrome

A multicenter, randomized, double-blind, placebo-controlled parallel controlled clinical study on the treatment of stable coronary artery disease with Renshen Jianxin Capsules due to Qi deficiency and blood stasis syndrome

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075303
Enrollment
Unknown
Registered
2023-08-31
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

stable coronary artery disease

Interventions

test group:Renshen Jianxin Capsule+Conventional Medicine Treatment
control group:placebo+Conventional Medicine Treatment

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for stable coronary heart disease. 2. Meet the diagnostic criteria for Qi deficiency and blood stasis syndrome in traditional Chinese medicine. 3. Subjects aged 18-75 years old. 4. The subject has informed consent and voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with acute myocardial infarction, unstable angina pectoris, and angina pectoris (CCS) grade IV. 2. Patients with ST-T changes in electrocardiogram due to digitalis drugs, myocardial hypertrophy, left bundle branch block, etc. 3. Patients who anticipate or plan to undergo coronary, cerebrovascular, or peripheral arterial revascularization surgery or other major surgical procedures at random time points. 4. Those who simultaneously suffer from organ damage or diseases such as severe cerebrovascular disease (cerebral hemorrhage, subarachnoid hemorrhage, large area cerebral infarction); Poor control of diabetes (fasting blood glucose>11 mmol/L) or patients with kidney disease and peripheral neuropathy; Decompensated heart failure (NYHA III-IV), recurrent malignant arrhythmia, poorly controlled hypertension (controlled systolic blood pressure = 180mmHg or diastolic blood pressure = 100mmHg); Patients with a history of using a pacemaker and experiencing cerebrovascular disease within 1 year; Respiratory failure, chronic lung disease with difficulty breathing; Patients with renal insufficiency (creatinine above the upper limit of normal value, glomerular filtration rate (eGFR)50%; Narrow proximal diameter of the anterior descending branch>70%; Stenosis of lesion blood vessel diameter = 90%; When the diameter of the diseased vessel is narrower than 90%, the blood flow reserve score is = 0.8. 8. Before screening, any laboratory test indicator meets the following criteria: admission liver and kidney function prompt: ALT, AST>1.5 times the upper limit of normal value, Cr>1.2 times the upper limit of normal value (refer to the range of normal values checked in the laboratory of the research center); Other clinically significant laboratory test abnormalities that have been determined by the researcher to be unsuitable for inclusion. 9. Patients who are deemed unsuitable by the researchers to participate in this clinical trial. 10. Patients who are unable or unwilling to cooperate due to the merger of other mental illnesses; Suspected or with a history of alcohol or drug abuse. Note: Any one or more of the above items should be excluded and cannot be selected.

Design outcomes

Primary

MeasureTime frame
Syndrome score of TCM;Seattle Angina Scale (SAQ) score;

Secondary

MeasureTime frame
Angina Severity (CCS) Rating;Number of angina attacks (per week);electrocardiogram;Nitroglycerin dosage (weekly);Nitroglycerin dosage during angina pectoris attack (each time);ultrasound cardiogram;

Countries

China

Contacts

Public ContactLi YunLun

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

li.yunlun@163.com+86 138 6910 2760

Outcome results

None listed

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