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A randomized, double-blind, placebo-controlled, multicenter clinical trial of Xuanbi Antong Granules in the treatment of borderline stenosis

Research on the effect of Traditional Chinese Medicine on the intermediate coronary artery stenosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013189
Enrollment
Unknown
Registered
2017-10-31
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

borderline stenosis

Interventions

Treatment group:Xuanbi Antong Granules
Placebo group:Placebo

Sponsors

Guang'anmen Hospital,China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Coronary CT or coronary arteriography shows that diameter stenosis is from 30 percent to 70 percent and have not been given PCI or CABG; 2. Patients who are diagnosed as coronary atherosclerotic heart disease; 3. Patients who are diagnosed as phlegm, blood stasis and heat syndrome by TCM; 4. Patients who are older than 30 and younger than 75; 5. Patients agree to the study protocol and provide informed, written consent.;Inclusion criteria: 1. Coronary CT or coronary arteriography shows that diameter stenosis is from 30 percent to 70 percent and have not been given PCI or CABG; 2. Patients who are diagnosed as coronary atherosclerotic heart disease; 3. Patients who are diagnosed as phlegm, blood stasis and heat syndrome by TCM; 4. Patients who are older than 30 and younger than 75; 5. Patients agree to the study protocol and provide informed, written consent.;Inclusion criteria: 1. Coronary CT or coronary arteriography shows that diameter stenosis is from 30 percent to 70 percent and have not been given PCI or CABG; 2. Patients who are diagnosed as coronary atherosclerotic heart disease; 3. Patients who are diagnosed as phlegm, blood stasis and heat syndrome by TCM; 4. Patients who are older than 30 and younger than 75; 5. Patients agree to the study protocol and provide informed, written consent.;Inclusion criteria: 1. Coronary CT or coronary arteriography shows that diameter stenosis is from 30 percent to 70 percent and have not been given PCI or CABG; 2. Patients who are diagnosed as coronary atherosclerotic heart disease; 3. Patients who are diagnosed as phlegm, blood stasis and heat syndrome by TCM; 4. Patients who are older than 30 and younger than 75; 5. Patients agree to the study protocol and provide informed, written consent.;Inclusion criteria: 1. Coronary CT or coronary arteriography shows that diameter stenosis is from 30 percent to 70 percent and have not been given PCI or CABG; 2. Patients who are diagnosed as coronary atherosclerotic heart disease; 3. Patients who are diagnosed as phlegm, blood stasis and heat syndrome by TCM; 4. Patients who are older than 30 and younger than 75; 5. Patients agree to the study protocol and provide informed, written consent.

Exclusion criteria

Exclusion criteria: 1. Chest pain caused by severe left main coronary artery lesions, severe valvular heart disease (aortic stenosis), severe psychoneurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, gallbladder heart syndrome, gastroesophageal reflux disease; 2. Uncontrolled hypertension with SBP=160mmHg or DBP=100mmHg, severe cardiac insufficiency with EF<35%, severe arrhythmia (Fast Atrial Fibrillation, Atrial Flutter, paroxysmal ventricular tachycardia, atrioventricular block higher that second degree subtype II, complete bundle branch block); 3. Patients with severe primary diseases like heart, brain, liver, kidney, hemopoietic system related diseases, and patients whose ALT or AST is higher than 1.5 times of the upper limit, patients with abnormal renal function or insulin dependent diabetes mellitus; 4. Patients with depression or anxiety; 5. Stroke or resuscitated sudden death in the past 6 months; 6. Hyperthyroidism with TSH levels more than 1.5 times upper limit of narmal; 7. Patients with malignant tumor; 8. Pregnant women or breast feeding women; 9. Reference vessel diameter of the target vessel < 2.5mm, or there is no non-calcified plaque in the main coronary artery, or severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for CTA procedure; 10. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible); 11. Patients with allergic constitution or are allergic to many kinds of TCM herbs and Iodine; 12. Patients with low compliance, who might miss the follow-up; 13. Patients who participant in other clinical trials in last 1 month.;Exclusion criteria: 1. Chest pain caused by severe left main coronary artery lesions, severe valvular heart disease (aortic stenosis), severe psychoneurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, gallbladder heart syndrome, gastroesophageal reflux disease; 2. Uncontrolled hypertension with SBP=160mmHg or DBP=100mmHg, severe cardiac insufficiency with EF<35%, severe arrhythmia (Fast Atrial Fibrillation, Atrial Flutter, paroxysmal ventricular tachycardia, atrioventricular block higher that second degree subtype II, complete bundle branch block); 3. Patients with severe primary diseases like heart, brain, liver, kidney, hemopoietic system related diseases, and patients whose ALT or AST is higher than 1.5 times of the upper limit, patients with abnormal renal function or insulin dependent diabetes mellitus; 4. Patients with depression or anxiety; 5. Stroke or resuscitated sudden death in the past 6 months; 6. Hyperthyroidism with TSH levels more than 1.5 times upper limit of narmal; 7. Patients with malignant tumor; 8. Pregnant women or breast feeding women; 9. Reference vessel diameter of the target vessel < 2.5mm, or there is no non-calcified plaque in the main coronary artery, or severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for CTA procedure; 10. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible); 11. Patients with allergic constitution or are allergic to many kinds of TCM herbs and Iodine; 12. Patients with low compliance, who might miss the follow-up; 13. Patients who participant in other clinical trials in last 1 month.;Exclusion criteria: 1. Chest pain caused by severe left main coronary artery lesions, severe valvular heart disease (aortic stenosis), severe psychoneurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, gallbladder heart syndrome, gastroesophageal reflux disease; 2. Uncontrolled hypertension with SBP=160mmHg or DBP=100mmHg, severe cardiac insufficiency with EF<35%, severe arrhythmia (Fast Atrial Fibrillation, Atrial Flutter, paroxysmal ventricular tachycardia, atrioventricular block higher that second degree subtype II, complete bundle branch block); 3. Patients with severe primary diseases like heart, brain, liver, kidney, hemopoietic system related diseases, and patients whose ALT or AST is higher than 1.5 times of the upper limit, patients with abnormal renal function or insulin dependent diabetes mellitus; 4. Patients with depression or anxiety; 5. Stroke or resuscitated sudden death in the past 6 months; 6. Hyperthyroidism with TSH levels more than 1.5 times upper limit of narmal; 7. Patients with malignant tumor; 8. Pregnant women or breast feeding women; 9. Reference vessel diameter of the target vessel < 2.5mm, or there is no non-calcified plaque in the main coronary artery, or severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for CTA procedure; 10. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible); 11. Patients with allergic constitution or are allergic to many kinds of TCM herbs and Iodine; 12. Patients with low compliance, who might miss the follow-up; 13. Patients who participant in other clinical trials in last 1 month.;Exclusion criteria: 1. Chest pain caused by severe left main coronary artery lesions, severe valvular heart disease (aortic stenosis), severe psychoneurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, gallbladder heart syndrome, gastroesophageal reflux disease; 2. Uncontrolled hypertension with SBP=160mmHg or DBP=100mmHg, severe cardiac insufficiency with EF<35%, severe arrhythmia (Fast Atrial Fibrillation, Atrial Flutter, paroxysmal ventricular tachycardia, atrioventricular block higher that second degree subtype II, complete bundle branch block); 3. Patients with severe primary diseases like heart, brain, liver, kidney, hemopoietic system related diseases, and patients whose ALT or AST is higher than 1.5 times of the upper limit, patients with abnormal renal function or insulin dependent diabetes mellitus; 4. Patients with depression or anxiety; 5. Stroke or resuscitated sudden death in the past 6 months; 6. Hyperthyroidism with TSH levels more than 1.5 times upper limit of narmal; 7. Patients with malignant tumor; 8. Pregnant women or breast feeding women; 9. Reference vessel diameter of the target vessel < 2.5mm, or there is no non-calcified plaque in the main coronary artery, or severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for CTA procedure; 10. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible); 11. Patients with allergic constitution or are allergic to many kinds of TCM herbs and Iodine; 12. Patients with low compliance, who might miss the follow-up; 13. Patients who participant in other clinical trials in last 1 month.;Exclusion criteria: 1. Chest pain caused by severe left main coronary artery lesions, severe valvular heart disease (aortic stenosis), severe psychoneurosis, climacteric syndrome, hyperthyroidism, cervical spondylosis, gallbladder heart syndrome, gastroesophageal reflux disease; 2. Uncontrolled hypertension with SBP=160mmHg or DBP=100mmHg, severe cardiac insufficiency with EF<35%, severe arrhythmia (Fast Atrial Fibrillation, Atrial Flutter, paroxysmal ventricular tachycardia, atrioventricular block higher that second degree subtype II, complete bundle branch block); 3. Patients with severe primary diseases like heart, brain, liver, kidney, hemopoietic system related diseases, and patients whose ALT or AST is higher than 1.5 times of the upper limit, patients with abnormal renal function or insulin dependent diabetes mellitus; 4. Patients with depression or anxiety; 5. Stroke or resuscitated sudden death in the past 6 months; 6. Hyperthyroidism with TSH levels more than 1.5 times upper limit of narmal; 7. Patients with malignant tumor; 8. Pregnant women or breast feeding women; 9. Reference vessel diameter of the target vessel < 2.5mm, or there is no non-calcified plaque in the main coronary artery, or severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems inappropriate for CTA procedure; 10. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible); 11. Patients with allergic constitution or are allergic to many kinds of TCM herbs and Iodine; 12. Patients with low compliance, who might miss the follow-up; 13. Patients who participant in other clinical trials in last 1 month.

Design outcomes

Primary

MeasureTime frame
index of plaque by MSCT;TC, TG, LDL, HDL;

Secondary

MeasureTime frame
withdrawal and decreasing rate of nitroglycerin;ECG;angina frequency;SAQ;MACE;secondary ACE;

Countries

China

Contacts

Public ContactJie Wang;Jie Wang;Jie Wang;Jie Wang;Jie Wang ;;;;

Guang'anmen Hospital, China Academy of Chinese Medical Sciences;Guang'anmen Hospital, China Academy of Chinese Medical Sciences;Guang'anmen Hospital, China Academy of Chinese Medical Sciences;Guang'anmen Hospital, China Academy of Chinese Medical Sciences;Guang'anmen Hospital, China Academy of Chinese Medical Sciences

wangjie0103@126.com;wangjie0103@126.com;wangjie0103@126.com;wangjie0103@126.com;wangjie0103@126.com+86 010-88001229;+86 010-88001229;+86 010-88001229;+86 010-88001229;+86 010-88001229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026