A Randomized Controlled Trial About the Efficacy and Safety of Naoxintong Capsule for Treating Chronic Stable Angina

Phase 4

Recruiting

• Conditions: Chronic Stable Angina

• Registration Number: ITMCTR2100004619
• Lead Sponsor: The Second Clinical Medical College of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) A diagnosis of CHD and the provision of exact imaging information (coronary angiography or computed tomography coronary angiography confirmation of stenosis greater than 50% of at least one major branch of the coronary artery luminal diameter, or nuclear perfusion scan diagnosed as CAD). CCS classification of angina grade II;
(2) The onset of angina pectoris >= 3 months previous and the frequency of angina attack >= twice a week;
(3) Age between 35 and 75, regardless of gender;
(4) Signed informed consent by participants or surrogates.

Exclusion Criteria

(1) Uncontrolled or mismanaged blood pressure and blood glucose. Severe cardiopulmonary insufficiency, or severe arrhythmia (rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia second degree and greater than a second degree atrioventricular (AV) block). Acute MI in the past 2 months, or has undergone coronary revascularization in the past 12 months.
(2) Renal dysfunction, male serum creatinine >2.5 mg/ dl (>220 µmol/L) or female serum creatinine >2.0 mg/ dl (>175 µmol/L). Serious liver disease (expression of aminotransferase (ALT) and aspartate aminotransferase (AST) of 1.5 times higher than the normal upper limit).
(3) Factors that precluded satisfactory interpretation of the electrocardiogram (ECG) (e.g. digoxin therapy, left bundle branch block, implanted with pacemaker, left ventricular hypertrophy, or electrolyte disturbance).
(4) Complications with a serious bone joint disease or other comorbidities that may interfere with ability to perform required ETT.
(5) Patients planning to undergo coronary revascularization during the study period.
(6) Patients who might be allergic or are known to be allergic to ingredients of the study drug.
(7) Pregnant, pregnancy planners or lactating women.
(8) Patients who are allergic to NXT capsule.
(9) Substance abuse, alcohol and drug dependence in the last 2 years.
(10) Patients who participated in other clinical drug trials within 1 month.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes of curative effect of angina pectoris symptoms;Therapeutic effect of TCM syndromes;