Clinical Trial Scheme of Xinnaoning Capsule
关键词
抽象
描述
Coronary heart disease angina pectoris is a kind of heart disease caused by myocardial ischemia and anoxia caused by coronary atherosclerosis. It belongs to the category of "chest obstruction" and "heartache" in traditional Chinese medicine. One of its common pathogenesis is stagnation of Qi and blood stasis, blockage of blood vessels, so it should be treated by activating blood circulation and removing blood stasis, dredging channels and collaterals, as well as tranquilizing Qi and tranquilizing spirit, in order to achieve the goal of blood stasis to remove new life and nourish the blood vessels of viscera and viscera. Xinnaoning Capsule (Chinese medicine approved character: Z20025697) is produced by Guizhou Jingcheng Pharmaceutical Co., Ltd. It has the functions of activating blood circulation, promoting Qi circulation, dredging collaterals and relieving pain.Xinnaoning Capsule has not had any adverse reactions for many years after it was put on the market. In this study, a randomized, double-blind, placebo-controlled, multi-center, efficacy test design was used to evaluate the efficacy and safety of Xinnaoning Capsule in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome) .
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 03/27/2019 |
| 提交的预估入学人数: | 04/09/2019 |
| 首次发布: | 04/15/2019 |
| 上次提交的更新: | 04/09/2019 |
| 最近更新发布: | 04/15/2019 |
| 实际学习开始日期: | 05/14/2018 |
| 预计主要完成日期: | 11/30/2019 |
| 预计完成日期: | 03/31/2020 |
状况或疾病
干预/治疗
Drug: study group
Other: Xinnaoning Capsule Simulator
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: study group Introduction period: 2 weeks, time window (±2 days). Dosage regimen: Take Xinnaoning Capsule Simulator 3 tablets per time, 3 times per day, orally, after meals.
The treatment period: 12 weeks, time window (±4 days). Dosage regimen:Take Xinnaoning Capsule 3 tablets per time, 3 times per day, orally, after meals.
Dosage form:Capsule | Drug: study group Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate. |
| Placebo Comparator: control group Introduction period: 2 weeks, time window (±2 days). Dosage regimen: Take Xinnaoning Capsule Simulator 3 tablets per time, 3 times per day, orally, after meals.
The treatment period: 12 weeks, time window (±4 days). Dosage regimen:Take Xinnaoning Capsule Simulator 3 tablets per time, 3 times per day, orally, after meals.
Dosage form:Capsule |
资格标准
| 有资格学习的年龄 | 30 Years 至 30 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. the changes of curative effect of angina pectoris symptoms [Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days]
次要成果指标
1. Therapeutic effect of TCM syndromes [Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days]
2. Grading changes of severity of angina pectoris [Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days]
3. Changes in the number of angina attacks per week [through study completion, an average of 14 weeks]
4. Nitroglycerin dosage [through study completion, an average of 14 weeks]
5. Seattle Angina Questionnaire,SAQ [Visit1:introduction period,-14±2days; Visit2:treatment period,-4~0day; Visit3:treatment period,4weeks±4days; Visit4:treatment period,8weeks±4days; Visit5:treatment period, 12weeks±4days]
6. Blood homocysteine [visti1:treatment period,-4~0day; Visit2:treatment period,12weeks±4days]
7. Incidence of cardiovascular events [Visit1:treatment period,-4~0day; Visit2:treatment period,4weeks±4days; Visit3:treatment period,8weeks±4days; Visit4:treatment period, 12weeks±4days]
