Clinical Trial Scheme of Xinnaoning Capsule

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, double-blind, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of Xinnaoning capsule in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)

Criteria

Inclusion Criteria:

• Refer to the Guidelines for Diagnosis and Treatment of Chronic Stable Angina issued by the Chinese Medical Association in 2007, 2012ACP/ACCF/AHA/AATS/PCNA/STS (Guidelines for Diagnosis and Management of Stable Ischemic Heart Disease: American Heart Foundation/American Heart Association/American Medical Association/American Thoracic Surgery Association/American Association for Cardiovascular Preventive Nursing/American Association for Cardiovascular Angiography and Intervention/American Thoracic Association The Diagnosis of Stable Ischemic Heart Disease: Guidelines for Clinical Practice, Guidelines for the Management of Stable Coronary Artery Diseases in 2013 ESC, which can diagnose coronary heart disease in accordance with any of the following:

1. Has a clear history of old myocardial infarction, or PCI history, or bypass history

2. Coronary angiography (results indicate at least one coronary artery stenosis with stenosis (>50%) or coronary CTA suggests stenosis with stenosis (>50%)

• Those who met the diagnostic criteria of chronic stable angina pectoris: those who had a history of angina pectoris more than 1 month and had no significant changes in the degree, frequency, nature and inducing factors of angina pectoris

• The severity of angina pectoris of the Canadian Cardiovascular Society (CCS) was classified as Grade I to Grade III, and angina pectoris occurred more than twice a week

• The syndrome differentiation of TCM is Qi stagnation and blood stasis syndrome

• Age ranges from 30 to 79 years old

• Sign the informed consent

Exclusion Criteria:

• Severe cardiopulmonary insufficiency (grade III, IV, severe abnormal pulmonary function);

• Poor control of hypertension (systolic blood pressure (> 160 mmHg) or diastolic blood pressure (> 100 mmHg) after treatment;

• Complicated with liver and kidney function damage, ALT, AST (> 1.5 times of the upper limit of normal value), or Cr (> the upper limit of normal value), combined with hematopoietic system and other serious primary diseases;

• Acute myocardial infarction within 3 months after interventional therapy;

• Cardiac pacemaker;

• Pregnancy, lactation or pregnancy planners;

• Anaphylactic constitution or allergic to known ingredients of research drugs;

• Chest pain caused by other causes (moderate anemia, hyperthyroidism, etc.)

• Those who participated in other clinical drug trials within one month;

• According to the judgement of the researchers, it is not advisable to participate in clinical researchers.

• Other factors affecting ST-T changes in ECG, such as myocardial hypertrophy, left bundle branch block, etc.