Clinical Study of Chinese Herbal Compound Qidan Xiaoke Granules in Patients After Coronary Revascularization

1. Evaluate the efficacy and safety of Qidan Xiaohe granules in patients after coronary revascularization surgery;
2. Develop a traditional Chinese medicine rehabilitation treatment plan and evaluation system for the use of Qidan Xiaohe granules after coronary revascularization surgery;
3. Demonstrate the advantages of traditional Chinese medicine rehabilitation treatment in the postoperative management of coronary revascularization surgery and provide high-level evidence-based medical evidence for the development of traditional Chinese medicine rehabilitation treatment plans.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Myocardial Revascularization
• Intervention / Treatment: Drug: Qidan Xiaoke Granules + Standard Medical Therapy; Drug: Placebo + Standard Medical Therapy

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients who have undergone coronary revascularization will be randomly assigned to receive either Qidan Xiaohe Granules or a matching placebo, in addition to standard medical therapy. The treatment period lasts 12 weeks, and participants will be followed up for a total of 48 weeks. The main goal is to see whether adding the Chinese herbal medicine reduces the occurrence of major adverse cardiovascular events such as death, heart attack, recurrent chest pain, or repeat revascularization. Secondary goals include improvements in heart function, quality of life, and traditional Chinese medicine symptom scores. Safety will be monitored throughout the study. The results will help determine whether this herbal formula can be recommended as an effective and safe rehabilitation treatment for patients after coronary revascularization.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Liu Qiang, PhD; Phone Number: +86 13588121905; Email: 19981011@zcmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-80 years old;
2. no gender limitation;
3. Meets the diagnostic criteria for coronary heart disease;
4. Accepts effective PCI procedure;
5. Voluntarily participates and signs a written informed consent form.

Exclusion Criteria:

1. Severe hepatic and/or renal insufficiency
2. Severe electrolyte disorders
3. Severe hematological diseases or malignant tumors
4. Pregnant or breastfeeding women
5. Patients with mental illness
6. Cognitive impairment (e.g., dementia, post-stroke cognitive impairment) leading to inability to communicate normally
7. Planning to undergo another revascularization surgery in the near future
8. Other severe cardiovascular diseases (e.g., uncontrolled hypertension, angina pectoris, rapid arrhythmias, high-degree or complete atrioventricular block without a pacemaker implanted, acute severe aortic stenosis, decompensated heart failure (NYHA Class IV), deep vein thrombosis, obstructive hypertrophic cardiomyopathy, acute pericarditis or myocarditis, acute endocarditis, acute aortic dissection, etc.)
9. Acute pulmonary embolism and chronic lung diseases with dyspnea symptoms (occurring at rest or with minimal exertion)
10. Explicit exclusion criteria (bleeding history within 1 month, active bleeding, bleeding tendency, currently using anticoagulants)
11. Participants in other interventional clinical trials within the past month
12. Allergy to known components of the investigational drug (Qidan Xiaohe Granules)
13. Other conditions deemed unsuitable for participation in the trial by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy , statins, beta-blockers, ACEI/ARB, and other medications as clinically indicated. In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks. The granules are dissolved in warm water before administration. The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline. The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.	Drug: Qidan Xiaoke Granules + Standard Medical Therapy; Participants in this arm receive standard medical therapy for coronary heart disease according to current guidelines, including dual antiplatelet therapy, statins, beta-blockers, ACEI/ARB, and other medications as clinically indicated. In addition, they take Qidan Xiaoke Granules orally, one sachet twice daily for 12 consecutive weeks. The granules are dissolved in warm water before administration. The intervention period is 12 weeks, with follow-up assessments at 24, 36, and 48 weeks after baseline. The primary outcome is the incidence of major adverse cardiovascular events (MACE) within 48 weeks.
Placebo Comparator: Control Group; Participants in this arm receive the same standard medical therapy as the experimental group. In addition, they take a placebo matching the Qidan Xiaoke Granules in appearance, taste, odor, and packaging at the same dosage regimen: one sachet twice daily for 12 weeks. The placebo has no pharmacological activity related to the investigational product. The treatment and follow-up schedule are identical to the experimental group.	Drug: Placebo + Standard Medical Therapy; Participants in this arm receive the same standard medical therapy as the experimental group. In addition, they take a placebo matching the Qidan Xiaoke Granules in appearance, taste, odor, and packaging at the same dosage regimen: one sachet twice daily for 12 weeks. The placebo has no pharmacological activity related to the investigational product. The treatment and follow-up schedule are identical to the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Major Adverse Cardiovascular Events (MACE)	MACE is defined as a composite endpoint including the following seven events: (1) all-cause death; (2) subacute stent thrombosis; (3) peri-procedural myocardial infarction; (4) recurrent myocardial infarction; (5) recurrent unstable angina; (6) repeat revascularization ; and (7) rehospitalization due to angina or heart failure. All events are adjudicated by an independent Clinical Endpoint Committee blinded to treatment allocation, based on source documents.	Within 48 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine Syndrome Score	The scale evaluates 14 symptoms. Each symptom is scored as 0 (none), 1 (mild), 2 (moderate), or 3 (severe). Tongue appearance (color, coating) and pulse pattern are also recorded. With higher scores indicating more severe TCM syndrome. Assessments are performed by two trained TCM physicians independently; discrepancies are resolved by a third senior physician.	Baseline (day 0), week 6, week 12, week 24, week 36, week 48
Echocardiographic Parameters of Cardiac Structure and Function	Echocardiography is performed using a standardized protocol at each participating site. Parameters measured include: (1) Left ventricular ejection fraction ; (2) Left ventricular end-diastolic diameter (LVEDD); (3) Left ventricular end-systolic diameter (LVESD); (4) Left ventricular posterior wall thickness (LVPW); (5) Interventricular septal thickness (IVS); (6) E/A ratio (peak velocity of early to late diastolic filling); (7) Average E/e' ratio (mitral inflow to annular velocity). All measurements are performed by certified sonographers following a centralized training program.	Baseline, week 12
24-Hour Holter Monitoring Parameters	Mean heart rate, PVC count, paired PVCs/ventricular tachycardia, atrial fibrillation, ST-segment depression events, etc.	Baseline, week 12
Minnesota Living with Heart Failure Questionnaire (MLHFQ)	The MLHFQ is a 21-item, self-administered questionnaire that assesses the impact of heart failure on health-related quality of life. Each item is scored from 0 (no impact) to 5 (very severe impact). With higher scores indicating worse quality of life. The questionnaire is administered in the validated Chinese version.	Baseline, week 6, week 12, week 24, week 36, week 48
Creatine Kinase-Myocardial Band (CK-MB)	Serum CK-MB measured from fasting blood samples.	Baseline, week 12
Serum Lipid Profile	Fasting TC, TG, LDL-C, HDL-C measured by enzymatic methods.	Baseline, week 12
Fasting Glucose	Fasting blood glucose measured using standard laboratory methods.	Baseline, week 12
Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.	Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded.	Baseline, week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cell count	As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.	Baseline, week 12
Haemoglobin concentration	Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.	Baseline, week 12
White blood cell count	Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.	Baseline, week 12
Platelet count	Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.	Baseline, week 12
Haematocrit	Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.	Baseline, week 12
Alanine transaminase	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Aspartate transaminase	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Alkaline phosphatase	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Potassium	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Sodium	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Total bilirubin	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Blood urea nitrogen	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Creatinine	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Uric acid	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12
Homocysteine	As part of the objective assessment, blood samples were taken at the time points specified in the study to test liver and kidney function markers.	Baseline, week 12

Collaborators and Investigators

• Sponsor: Liu Qiang

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: ZSLL-KY-2026-028-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data not shared due to patient privacy protection, ethical constraints, and national regulations on human genetic resources.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No