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Randomized double-blind controlled clinical trial of efficacy and safety of Xinyue capsule in the treatment of coronary heart disease patients with fatigue

Randomized double-blind controlled clinical trial of efficacy and safety of Xinyue capsule in the treatment of coronary heart disease patients with fatigue

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075518
Enrollment
Unknown
Registered
2023-09-07
Start date
2023-09-11
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Coronary heart disease

Interventions

Experimental group:Xinyue capsule
Control group:placebo

Sponsors

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 30~75 years old, gender unlimited; 2. In accordance with the diagnostic and Treatment Guidelines for Chronic Stable Angina Pectoris (2007 edition) of the Chinese Medical Association, the diagnostic criteria for stable angina pectoris are as follows: There is angina pectoris attack, but the degree, frequency, time and inducment of the attack do not change within a few weeks: ? There were dynamic changes in the ECG during chest pain attack, which were consistent with the ECG of myocardial ischemia, and the 24-hour dynamic ECG changes were consistent with the symptoms of ST; Coronary angiography or coronary CT=50% stenosis; ? Patients with asymptomatic or stable symptoms after ACS stabilization; ? microcirculatory angina pectoris; 3. Consistent with TCM Qi and Yin deficiency syndrome type; 4. Meet the FS14 fatigue scale score =3, and do not suffer from other diseases that can explain chronic fatigue symptoms; 5. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled grade 3 hypertension (=180/100mmHg) or hypotension (< 90/60mmHg); 2. History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke with unknown type) or lower limb artery disease in the past 6 months; 3. History of pregnancy, preparation or suspected pregnancy, miscarriage, breastfeeding or post-delivery within the last 6 months. 4. Combined with episodic bronchial asthma or chronic obstructive pulmonary disease; 5. Severe allergy, known or likely to be allergic to the test drug or its components; 6. Known bleeding tendencies or bleeding disorders; 7. Complicated with severe hepatic and renal dysfunction (creatinine clearance =40ml/min or renal activity stage, serum transaminase =2× the upper limit of clinical reference value); 8. Excluding patients with heart failure, senile sarcopenia, tumor, anemia, hypothyroidism, myasthenia gravis, and psychiatric diseases; 9. The investigator believes that there may be other conditions affecting the clinical study.

Design outcomes

Primary

MeasureTime frame
Fatigue Scale (FS-14);

Secondary

MeasureTime frame
electrocardiogram;EQ5D scale;

Countries

China

Contacts

Public ContactXiaoping Meng

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

xiopingmeng@126.com+86 131 8088 9430

Outcome results

None listed

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