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A randomized, double-blind, placebo-controlled, multicenter clinical trial of Jiuxin pill in the treatment of stable angina pectoris in patients with coronary heart disease

A randomized, double-blind, placebo-controlled, multicenter clinical trial of Jiuxin pill in the treatment of stable angina pectoris in patients with coronary heart disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006092
Enrollment
Unknown
Registered
2022-06-11
Start date
2022-05-31
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Stable Angina Pectoris

Interventions

Control group :Western medicine routine treatment + Jiuxin pill placebo
Treatment group :Western medicine routine treatment + Jiuxin pill

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1.age from 35 to 74 (including boundary value), gender is not limited; 2.Conform to the western medicine diagnostic criteria for stable angina pectoris of coronary heart disease; 3.The history of stable angina pectoris shall not be less than 2 months; 4.The average number of angina pectoris attacks per week= 1 in the first month before being selected; 5.Canadian Cardiovascular Society (CCS) angina pectoris classification is grade II - III; 6.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with myocardial infarction in recent 3 months; 2.Patients who have received PCI or other cardiac surgery (such as CABG) in the past 1 year; 3.Patients who plan to undergo coronary revascularization (CABG or PCI) within 2 months; 4.Patients with unstable angina pectoris, intractable heart failure, cardiogenic shock, severe heart valve disease and other serious cardiovascular diseases; 5.Patients with poorly controlled hypertension (systolic blood pressure = 160mmHg or diastolic blood pressure = 100mmHg after treatment); 6.Patients with severe respiratory diseases such as severe pulmonary insufficiency; 7.Patients with severe liver and kidney diseases such as liver dysfunction (alanine aminotransferase or aspartate aminotransferase levels more than 2 times higher than the normal value), renal dysfunction (creatinine level is more than 2 times higher than the normal value); 8.Patients with malignant tumor, severe anemia, severe renal artery stenosis and other serious diseases or conditions; 9.Patients with contraindications to exercise treadmill test; 10.Patients who have participated in other clinical studies in the past 2 months; 11.Patients who are allergy to known ingredients of the study drug; 12.Women with positive pregnancy test, planned pregnancy or lactation; 13.Patients who could not participate in the study due to recent infection, trauma and other reasons considered by the researchers.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Questionnaire (SAQ) Score;Treadmill Exercise Test: Total Exercise Time;

Secondary

MeasureTime frame
Borg Perceived Exertion After Exercise;Treadmill Exercise Test: Metabolic Equivalent;Scoring of Four Diagnostic Information of Traditional Chinese Medicine;Treadmill Exercise Test: Maximum ST Segment Depression;Usage of Nitroglycerin, Drug Withdrawal and Reduction Rate;Treadmill Exercise Test: 1-minute Heart Rate Recovery;Average Number of Angina Attacks Per Week;Incidence of Major Adverse Cardiovascular Events;

Countries

China

Contacts

Public ContactMao Jingyuan

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

jymao@126.com13820498886

Outcome results

None listed

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