Clinical trial NCT03914131: Clinical Trial Scheme of Xinnaoning Capsule
Official title: To Evaluate the Efficacy and Safety of Xinnaoning Capsule in Treating Chronic Stable Angina Pectoris (Qi Stagnation and Blood Stasis Syndrome) : a Randomized, Double-blind, Parallel Controlled, Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Stable Angina Pectoris
Qi Stagnation and Blood Stasis Syndrome
Lead sponsor: Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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) .

Eligibility 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.

Primary outcomes:
measure: the changes of curative effect of angina pectoris symptoms
timeFrame: 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
Secondary outcomes:
measure: Therapeutic effect of TCM syndromes
timeFrame: 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
measure: Grading changes of severity of angina pectoris
timeFrame: 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
measure: Changes in the number of angina attacks per week
timeFrame: through study completion, an average of 14 weeks
measure: Nitroglycerin dosage
timeFrame: through study completion, an average of 14 weeks
measure: Seattle Angina Questionnaire,SAQ
timeFrame: 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
measure: Blood homocysteine
timeFrame: visti1:treatment period,-4~0day; Visit2:treatment period,12weeks±4days
measure: Incidence of cardiovascular events
timeFrame: Visit1:treatment period,-4~0day; Visit2:treatment period,4weeks±4days; Visit3:treatment period,8weeks±4days; Visit4:treatment period, 12weeks±4days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Fengqin Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao JN, Zhang Y, Lan X, Chen Y, Li J, Zhang P, Wu LQ, Jia ST, Liu Y, Xu FQ. Efficacy and safety of Xinnaoning capsule in treating chronic stable angina (qi stagnation and blood stasis syndrome): Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2019 Aug;98(31):e16539. doi: 10.1097/MD.0000000000016539.