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A randomized, open-label, Parallel control clinical trial to evaluate the anti-atherosclerosis efficacy of Qishen capsule combined with atorvastatin on patients with chest pain (Qi deficiency and blood stasis type) (Pre-trial)

A randomized, open-label, Parallel control clinical trial to evaluate the anti-atherosclerosis efficacy of Qishen capsule combined with atorvastatin on patients with chest pain (Qi deficiency and blood stasis type) (Pre-trial)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013393
Enrollment
Unknown
Registered
2017-11-15
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-20

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

Conditions

chest pain (Qi deficiency and blood stasis type)

Interventions

experimental group :Qishen capsule + atorvastatin

Sponsors

Department of pharmacy, Anzhen Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Signed the informed consent; 2. Aged 30-70 years; 3. chest pain( Qi deficiency and blood stasis type); 4. dyslipidemia:2.266.2mmol/L and LDL-C=3.37mmol/L,or HDL-C1.5mm, protruding into the lumen and clear boundary; 7. ultrasound: 30%=carotid artery diameter stenosis rate =50%.;Inclusion criteria: 1. Signed the informed consent; 2. Aged 30-70 years; 3. chest pain( Qi deficiency and blood stasis type); 4. dyslipidemia:2.266.2mmol/L and LDL-C=3.37mmol/L,or HDL-C1.5mm, protruding into the lumen and clear boundary; 7. ultrasound: 30%=carotid artery diameter stenosis rate =50%.

Exclusion criteria

Exclusion criteria: 1. grade three hypertension group (severe), high risk of diabetes, acute heart failure, stroke, acute myocardial infarction, valvular heart disease, hypertrophic cardiomyopathy, unstable carotid plaque, revascularization or unstable patients with ACS secondary to other causes of unstable angina, peripheral vascular disease, its autoimmune diseases, blood diseases, malignant tumors, infectious diseases and patients with major surgery or trauma; 2. and the expected use of fibrates, ezetimibe and lipid-lowering effects of food supplements and other health products with additives; 3. use and expect more than 2 kinds of antihypertensive drugs (containing 2 kinds of antihypertensive drugs) or 2 or more kinds of hypoglycemic agents (2 kinds); 4. To be expected to use the blood stasis class containing ingredients of Chinese medicine drugs; 5. patients taking warfarin; 6. known to have allergies or allergies to components of the drug; 7. pregnant, lactating and pregnant planners; 8. drug abusers, alcoholics; 9. participated in other clinical studies in the past 1 months; 10. the researchers considered that the participants were not suitable for the experiment.;Exclusion criteria: 1. grade three hypertension group (severe), high risk of diabetes, acute heart failure, stroke, acute myocardial infarction, valvular heart disease, hypertrophic cardiomyopathy, unstable carotid plaque, revascularization or unstable patients with ACS secondary to other causes of unstable angina, peripheral vascular disease, its autoimmune diseases, blood diseases, malignant tumors, infectious diseases and patients with major surgery or trauma; 2. and the expected use of fibrates, ezetimibe and lipid-lowering effects of food supplements and other health products with additives; 3. use and expect more than 2 kinds of antihypertensive drugs (containing 2 kinds of antihypertensive drugs) or 2 or more kinds of hypoglycemic agents (2 kinds); 4. To be expected to use the blood stasis class containing ingredients of Chinese medicine drugs; 5. patients taking warfarin; 6. known to have allergies or allergies to components of the drug; 7. pregnant, lactating and pregnant planners; 8. drug abusers, alcoholics; 9. participated in other clinical studies in the past 1 months; 10. the researchers considered that the participants were not suitable for the experiment.

Design outcomes

Primary

MeasureTime frame
carotid plaque;Symptom score of TCM;;carotid plaque;Symptom score of TCM;

Secondary

MeasureTime frame
TC, TG, LDL-C, HDL-C;Biomarker;;TC, TG, LDL-C, HDL-C;Biomarker;

Countries

China

Contacts

Public ContactYang Lin;Yang Lin ;

Beijing Anzhen Hospital of Capital Medical University;Beijing Anzhen Hospital of Capital Medical University

linyang3623@163.com;linyang3623@163.com+86 010-64456045;+86 010-64456045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026