Clinical Trial Scheme of Xinnaoning Capsule

NCT ID: NCT03914131

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2020-04-30

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) .

Conditions

Chronic Stable Angina Pectoris; Qi Stagnation and Blood Stasis Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Xinnaoning Capsule

Intervention Type: DRUG

Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.

Xinnaoning Capsule Simulator

Intervention Type: OTHER

Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.

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

Group Type: PLACEBO_COMPARATOR

Xinnaoning Capsule Simulator

Intervention Type: OTHER

Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.

Interventions

Xinnaoning Capsule

Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.

Intervention Type: DRUG

Xinnaoning Capsule Simulator

Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.

Intervention Type: OTHER

Other Intervention Names

Xinnaoning; placebo

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengqin Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fengqin Xu, Doctor

Role: CONTACT

18800021979@163.com

010-62835113 ext. 010-62835113

Chunsheng Qiao

Role: CONTACT

qiaocs@drugevaluation.cn

010-58462584 ext. 010-58462584

Facility Contacts

Fengqin xu, Doctor

Role: primary

18800021979@163.com

010-62835113

References

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.

Reference Type: DERIVED

PMID: 31374015 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DHZD-XNNJN-001

Identifier Type: -

Identifier Source: org_study_id