Phase IV clinical study on the safety and effectiveness of Sanqi Longxuejie Capsules in the treatment of coronary heart disease with stable exertional angina pectoris (Grade I, II)
- Conditions
- coronary heart disease with stable exertional angina pectoris (Grade I, II)
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Adult patients 18 years of age = age = 75 years of age, regardless of gender;
(2) Meet the diagnostic criteria of western medicine for stable labor-induced angina pectoris (refer to the 2018 Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease);
(3) Angina pectoris is classified into grades ? and ?: grade ?: general physical activity (such as walking and climbing stairs) is not restricted, but angina pectoris occurs during strong, rapid or continuous exertion; grade ?: general physical activity is slightly restricted. Angina pectoris occurs within a few hours after walking fast, after a meal, cold or windy, mentally stressed, or within a few hours after waking up. Under normal circumstances, walking on flat ground for more than 200m or for climbing buildings above one floor is restricted;
(4) TCM syndromes conform to the heart and blood stasis syndrome: ? Fixed chest pain (4 points); ? Dark purple tongue or petechiae on the tongue (4 points); ? Purple sublingual vein (3 points); ? Dark purple complexion (3 points); ? petechiae or ecchymosis on the body (3 points); ? numbness of limbs (3 points); ? dark purple or dark red lips (2 points); ? astringent pulse (2 points). The score can be diagnosed by adding =8 points;
(5) Sign the informed consent form.
(1) Those who have been confirmed as acute coronary syndrome, severe myocarditis, severe arrhythmia, severe cardiac insufficiency (heart function grade IV or left ventricular ejection fraction (LVEF) <30% by echocardiography), and others Patients with chest pain caused by heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, biliary heart disease, gastroesophageal reflux, etc.;
(2) Angina pectoris is classified into Grade III~IV: Grade III: General physical activity is obviously restricted. Under normal circumstances, walking on flat ground within 200m, or walking on the ground floor can cause angina; Grade IV: Angina can occur during light activity or rest;
(3) Patients with poor control of hypertension (systolic blood pressure =180mmHg or diastolic blood pressure =110mmHg);
(4) Those with active bleeding or high risk of bleeding (such as those with peptic ulcer diagnosed within the last 3 months);
(5) Combined with severe liver and kidney damage (ALT, AST or total bilirubin> 2 times the upper limit of the normal reference value, or Scr> 1.5 times the upper limit of the normal reference value), combined with serious primary diseases such as hematopoietic system, malignant tumors, Mentally ill
(6) Women who are pregnant, planning to become pregnant or breast-feeding;
(7) Participants in other clinical trials within the past 3 months;
(8) Those who are allergic to the test drug or its ingredients;
(9) The investigator believes that it is unsuitable to participate in the clinical trial patients and patients who do not cooperate and have poor compliance due to other reasons.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seattle Angina Questionnaire;
- Secondary Outcome Measures
Name Time Method TCM Syndrome Score of Heart Blood Stasis Syndrome;SF36 quality of life scale score;Withdrawal rate and usage of nitroglycerin;