Clinical Trial Scheme of Xinnaoning Capsule

Beijing Duheng for Drug Evaluation and Research (DDER)

Status and phase: Unknown; Phase 4

Conditions: Qi Stagnation and Blood Stasis Syndrome; Chronic Stable Angina Pectoris

Treatments: Other: Xinnaoning Capsule Simulator; Drug: Xinnaoning Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03914131

DHZD-XNNJN-001

Details and patient eligibility

About

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).

Full 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) .

Enrollment: 240 estimated patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

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

Treatment:

Drug: Xinnaoning Capsule

Other: Xinnaoning Capsule Simulator

control group

Placebo Comparator group

Description:

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

Treatment:

Other: Xinnaoning Capsule Simulator