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Clinical Trial Scheme of Xinnaoning Capsule

Primary Purpose

Chronic Stable Angina Pectoris, Qi Stagnation and Blood Stasis Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xinnaoning Capsule
Xinnaoning Capsule Simulator
Sponsored by
Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina Pectoris

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xiyuan Hospital, Chinese Academy of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Changes in the number of angina attacks per week
Frequency of angina pectoris episodes per week
Nitroglycerin dosage
basic treatment
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.
Blood homocysteine
The changes of blood HCY before and after treatment are compared between the two groups.
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.

Full Information

First Posted
March 28, 2019
Last Updated
April 10, 2019
Sponsor
Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)
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1. Study Identification

Unique Protocol Identification Number
NCT03914131
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina Pectoris, Qi Stagnation and Blood Stasis Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm 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
Arm Title
control group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Xinnaoning Capsule
Other Intervention Name(s)
Xinnaoning
Intervention Description
Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.
Intervention Type
Other
Intervention Name(s)
Xinnaoning Capsule Simulator
Other Intervention Name(s)
placebo
Intervention Description
Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.
Primary Outcome Measure Information:
Title
the changes of curative effect of angina pectoris symptoms
Description
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.
Time Frame
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 Measure Information:
Title
Therapeutic effect of TCM syndromes
Description
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.
Time Frame
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
Title
Grading changes of severity of angina pectoris
Description
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.
Time Frame
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
Title
Changes in the number of angina attacks per week
Description
Frequency of angina pectoris episodes per week
Time Frame
through study completion, an average of 14 weeks
Title
Nitroglycerin dosage
Description
basic treatment
Time Frame
through study completion, an average of 14 weeks
Title
Seattle Angina Questionnaire,SAQ
Description
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.
Time Frame
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
Title
Blood homocysteine
Description
The changes of blood HCY before and after treatment are compared between the two groups.
Time Frame
visti1:treatment period,-4~0day; Visit2:treatment period,12weeks±4days
Title
Incidence of cardiovascular events
Description
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.
Time Frame
Visit1:treatment period,-4~0day; Visit2:treatment period,4weeks±4days; Visit3:treatment period,8weeks±4days; Visit4:treatment period, 12weeks±4days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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: Has a clear history of old myocardial infarction, or PCI history, or bypass history 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengqin Xu, Doctor
Phone
010-62835113
Ext
010-62835113
Email
18800021979@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunsheng Qiao
Phone
010-58462584
Ext
010-58462584
Email
qiaocs@drugevaluation.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengqin Xu, Doctor
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengqin xu, Doctor
Phone
010-62835113
Email
18800021979@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31374015
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.
Results Reference
derived

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Clinical Trial Scheme of Xinnaoning Capsule

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