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Efficacy and safety of Tongxinluo capsules combined with metoprolol tartrate in the treatment of angina pectoris in coronary heart disease: A study protocol of randomized, double-blind, placebo-controlled clinical trial

Efficacy and safety of Tongxinluo capsules combined with metoprolol tartrate in the treatment of angina pectoris in coronary heart disease: A study protocol of randomized, double-blind, placebo-controlled clinical trial

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220505005
Enrollment
114
Registered
2022-05-05
Start date
2022-05-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Angina pectoris has the characteristics of long duration, difficult to cure and easy to recur, thus seriously affects the quality of survival of patients. blockers are commonly used in the treatment of angina pectoris in coronary heart disease, but there are cases of drug resistance and adverse effects. There is evidence demonstrating that Tongxinluo capsules are reliable and safe in the treatment of angina pectoris in coronary heart disease. However, there is a lack of high-quality clinical stu

Interventions

Patients who met the study criteria will be randomly divided into treatment and control groups, with the treatment group receiving Tongxinluo capsules combined with metoprolol tartrate and the control
Experimental Other
Tongxinluo capsules combined with metoprolol tartrate

Sponsors

Pengcheng Ren
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.meeting the diagnostic criteria for coronary angina 2. 18 to 70 years old 3.Bruce Protocol 3 to 12 min 4. patients agreed to join this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.patients with drug allergy in this study 2. patients with acute cardiomyopathy or congestive heart failure within 3 months 3. ALT, AST or Cr up to 1.5 times the normal upper limit 4. those with communication impairment or poor compliance 5. women who are pregnant, preparing for pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Lipid levels 12 weeks TC; TG; LDL-C; and HDL-C.

Secondary

MeasureTime frame
Before and after treatment and at follow-up, the patients' left ventricular end-diastolic diameter (LVEDD) 12 weeks left ventricular end-systolic diameter (LVESD)

Countries

China

Contacts

Public ContactPengcheng Ren

No.1073 Erhuan South Road, Tangxiang Street, Dazu District, Chongqing

doctorr@163.com13290039891

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026