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Effect of Yangxinshi Tablet on Exercise capacity in Patients with Chronic Coronary Syndrome: a prospective, multicenter, randomized, open-label, blinded-endpoint clinical study

Effect of Yangxinshi Tablet on Exercise capacity in Patients with Chronic Coronary Syndrome: a prospective, multicenter, randomized, open-label, blinded-endpoint clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077227
Enrollment
Unknown
Registered
2023-11-01
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

Chronic Coronary Syndrome

Interventions

Experimental group:basic drug+yangxinshi tablet, 3 tablets/time and 3 times/day The treatment period was 24 weeks.
Control group:basic drug The treatment period was 24 weeks.

Sponsors

Shandong First Medical University affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Age between 18 and 75 years (including both age limits), with no limitation on sex; 2)CCS patients with stable disease and a clear diagnosis of coronary imaging (50% or more stenosis in at least one vessel) : stable angina pectoris, ischemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, or ACS or coronary revascularization > 3 months later; 3)Individuals with limited exercise tolerance above moderate and severe: the maximum distance of the 6-minute walking test is less than 450 meters, or the metabolic equivalent measured by the cardiopulmonary exercise test (treadmill) is less than 5METs; 4)Individuals voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1)Individuals with absolute and relative contraindications to cardiopulmonary exercise test(treadmill)) or 6-minute walk test; 2)Individuals with serious primary diseases or mental illnesses and malignant tumors that affect life span; 3)Individuals with pregnancy, planned or suspected pregnancy, miscarriage, breastfeeding, or after childbirth in the last 6 months; 4)There were other conditions that were judged by investigators, such as Individuals who were participating in other drug clinical trials or intervention studies, to be ineligible for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
6-minute walk test,(6MWT);

Secondary

MeasureTime frame
Borg scale;Incidence of Major Adverse Cardiac and Cerebrovascular Event (MACCE);

Countries

China

Contacts

Public ContactYuan Haitao

Shandong First Medical University affiliated Provincial Hospital

doctoryuanht@126.com+86 136 8863 8072

Outcome results

None listed

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