Clinical Trial Scheme of Xinnaoning Capsule

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

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Stable Angina Pectoris; Qi Stagnation and Blood Stasis Syndrome
• Intervention / Treatment: Drug: Xinnaoning Capsule; Other: Xinnaoning Capsule Simulator

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) .

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fengqin Xu, Doctor; Phone Number: 010-62835113 010-62835113; Email: 18800021979@163.com
• Study Contact Backup: Name: Chunsheng Qiao; Phone Number: 010-58462584 010-58462584; Email: qiaocs@drugevaluation.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Recruiting
      • Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
      • Contact: Fengqin xu, Doctor; Phone Number: 010-62835113; Email: 18800021979@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Xinnaoning Capsule; Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.; Other Names: Xinnaoning; Other: Xinnaoning Capsule Simulator; Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.; Other Names: placebo
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	Other: Xinnaoning Capsule Simulator; Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of curative effect of angina pectoris symptoms	The number of angina attacks, duration, degree of pain, and the dosage of nitroglycerin are used as indicators for scoring. Score ranges 0-15, the higher the score, the more severe the angina.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic effect of TCM syndromes	The main symptoms of Qi stagnation and blood stasis syndrome are chest pain, chest tightness, secondary symptoms such as palpitation, shortness of breath, chest swelling, fatigue, dark lips, dizziness, veins at the base of tongue, irritability, etc. The severity and presence of these symptoms are used as criteria for scoring. Score ranges 0-28.The higher the score, the more serious it is.	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
Grading changes of severity of angina pectoris	Reference to Canadian Cardiovascular Society (CCS) Angina Severity Classification Standard。Ⅰ：General physical activity does not cause angina pectoris, such as walking and going upstairs, but tension, rapid or sustained exertion can cause the onset of angina pectoris.Ⅱ：Daily physical activity is slightly restricted. Walking fast or upstairs, climbing high, walking after meals or upstairs, walking in cold or wind, and emotional excitement can cause angina or only occur within a few hours after waking up. It is limited to walk more than 200 meters or climb stairs above one floor at normal speed.Ⅲ：Daily physical activity is obviously limited, and angina pectoris can occur when walking 100-200 m at normal speed or climbing a staircase.Ⅳ：Angina symptoms can occur when you are slightly active or at rest.	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
Changes in the number of angina attacks per week	Frequency of angina pectoris episodes per week	through study completion, an average of 14 weeks
Nitroglycerin dosage	basic treatment	through study completion, an average of 14 weeks
Seattle Angina Questionnaire,SAQ	The Seattle Angina Questionnaire (SAQ) measured a total of L9 problems,including physical activity limitation, stable state of angina, frequency of angina attack, satisfaction with treatment, and knowledge of disease. A kind of Assessment of Seattle Scale: The Seattle Angina Scale was divided into 5 items and 19 items: Physical Activity Restriction (PL, Question 1), Angina Stable State (AS, Question 2), Angina Attack (AF, Question 3-4), Treatment Satisfaction (TS, Question 5-8), Disease Cognition (DS, Question 9-11), 19 items of 5 items and the total score of SAQ. The formula is transformed into standard integral, standard integral = (actual score - the lowest score in this respect) / (the highest score in this respect - the lowest score in this respect) * 100, the higher the score, the better the quality of life and the state of body function of patients.	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
Blood homocysteine	The changes of blood HCY before and after treatment are compared between the two groups.	visti1:treatment period,-4~0day; Visit2:treatment period,12weeks±4days
Incidence of cardiovascular events	Sudden cardiac death, acute myocardial infarction, heart failure, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, malignant arrhythmia, cardiogenic cerebrovascular accident, angina pectoris requiring hospitalization, etc.	Visit1:treatment period,-4~0day; Visit2:treatment period,4weeks±4days; Visit3:treatment period,8weeks±4days; Visit4:treatment period, 12weeks±4days

Collaborators and Investigators

• Sponsor: Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)
• Investigators: Principal Investigator: Fengqin Xu, Doctor, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Pain; Neurologic Manifestations; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Chest Pain; Syndrome; Angina Pectoris; Angina, Stable; Blind Loop Syndrome
• Other Study ID Numbers: DHZD-XNNJN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No