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New treatment option for Heart Failure
Official title Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
ClinicalTrials.gov ID: NCT07687186
What this study is testing
What is Qishen Yiqi Dripping Pills 2 bags?
Qishen Yiqi Dripping Pills 2 bags is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial will evaluate the efficacy and safety of Qishen Yiqi Dripping Pills in treatment of Chronic Heart Failure with reduced ejection fraction resorted from Coronary Heart Disease (Syndrome of Qi Deficiency with Blood Stasis).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male or female people aged ≥ 18 years and ≤80 years when signing the informed consent form.
- Conformed to the diagnostic criteria of coronary heart disease and chronic heart failure.
- Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis.
- NYHA Functional Classification Ⅱ-Ⅲ.
- Left ventricular ejection fraction (LVEF) \< 45% (modified two-plane Simpson method).
You likely can't join if
- Heart failure caused by other cardiovascular diseases, such as infectious endocarditis, cardiac amyloidosis, genetic abnormalities (genetic factors...
- Heart failure caused by other non-cardiovascular diseases, such as severe infection, autoimmune diseases, tumor metastasis or infiltration, pulmonary...
- Within 3 months before receiving the investigational drug, had acute myocardial infarction, undergone revascularization [percutaneous coronary...
- Planned to undergo revascularization (PCI, CABG, etc.) or left ventricular assist device (CRT, ICD, etc.) treatment, or other cardiac surgery during...
- Had severe, progressive, or uncontrolled diseases, including but not limited to immune system, endocrine system, blood system, urinary system, liver...
- Had uncontrolled hypertension (after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), or...
See the full eligibility criteria
- Male or female people aged ≥ 18 years and ≤80 years when signing the informed consent form.
- Conformed to the diagnostic criteria of coronary heart disease and chronic heart failure.
- Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis.
- NYHA Functional Classification Ⅱ-Ⅲ.
- Left ventricular ejection fraction (LVEF) \< 45% (modified two-plane Simpson method).
- Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization without adjustment of dose, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks.
- Voluntarily participate in the clinical trial, sign the informed consent form, and be able to understand and comply with the trial procedures.
- Heart failure caused by other cardiovascular diseases, such as infectious endocarditis, cardiac amyloidosis, genetic abnormalities (genetic factors related to hypertrophic obstructive cardiomyopathy, restrictive...
- Heart failure caused by other non-cardiovascular diseases, such as severe infection, autoimmune diseases, tumor metastasis or infiltration, pulmonary heart disease, primary pulmonary hypertension, secondary severe...
- Within 3 months before receiving the investigational drug, had acute myocardial infarction, undergone revascularization [percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)] treatment...
- Planned to undergo revascularization (PCI, CABG, etc.) or left ventricular assist device (CRT, ICD, etc.) treatment, or other cardiac surgery during the trial.
- Had severe, progressive, or uncontrolled diseases, including but not limited to immune system, endocrine system, blood system, urinary system, liver and gallbladder system, respiratory system, nervous system, mental...
- Had uncontrolled hypertension (after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), or had hypotension (systolic blood pressure \< 80 mmHg and/or diastolic...
- Severe arrhythmias such as ventricular tachycardia, second-degree type II or above sinus or atrioventricular conduction block without pacemaker treatment.
- Abnormal liver function tests [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of the normal value of the laboratory in this center], or abnormal renal function tests [serum...
- Glycated hemoglobin (HbA1c) ≥ 9.0%.
- Hemoglobin (Hb) \< 90 g/L.
- Serum potassium concentration \> 5.5 mmol/L.
- Need to take anticoagulants, dose stable for less than 1 month, or INR \> 3.0.
- Need to take antiplatelet drugs, dose stable for less than 1 month, and platelets lower than the lower limit of the normal value.
- Allergic to the Chinese medicine formula of Qishen YiQi (QSYQ) Dripping Pills (Astragalus membranaceus, Salvia miltiorrhiza, Panax notoginseng, and Dalbergia odorifera), or allergic to other Chinese medicines with the...
- Within 2 weeks before randomization, had received drugs affecting exercise tolerance assessment (such as trimetazidine, renozine, coenzyme Q10, levocarnitine, and androgens) or Chinese medicine preparations with the...
- Had absolute contraindications for the 6-minute walk test or was unable to complete the 6-minute walk test.
- Had participated in other treatment drug clinical trials within 1 month before screening.
- Pregnant or lactating women, or had a pregnancy plan or could not take effective contraceptive measures from the screening period to the end of the trial and within 1 month after the last administration.
- Any other circumstances where other researchers deem it inappropriate for a participant to take part in the trial, such as if the participant has potential issues with compliance, is unable to complete all the...
The study team makes the final eligibility decision.
Where it's taking place
- Bozhou, Anhui, China
- Hefei, Anhui, China
- Suzhou, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Qingyang, Gansu, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Yulin, Guangxi, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Xingtai, Hebei, China
- Zhangjiakou, Hebei, China
- Daqing, Heilongjiang, China
- Harbin, Heilongjiang, China
- Hebi, Henan, China
- Kaifeng, Henan, China
+ 30 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozhou, Anhui, China; Hefei, Anhui, China; Suzhou, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China and 44 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.