Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

January 8, 2025 updated by: Tasly Pharmaceutical Group Co., Ltd

A Multi-center, Randomized, Double-blind, Placebo-parallel Controlled, Standardise-loaded Ⅱ Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure

This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

QiShen YiQi Dripping Pills are oral, compound traditional chinese medicine prepatations. This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Hefei First People's Hospital
      • Huainan, Anhui, China
        • The first Hospital of Anhui University Of Science & Technology
      • Suzhou, Anhui, China
        • Suzhou Municipal Hospital
    • Beijing
      • Beijing, Beijing, China
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Fujian
      • Xiamen, Fujian, China
        • Xiamen Hospital of Traditional Chinese Medicine
    • Guangdong
      • Dongguan, Guangdong, China
        • Dongguan TCM Hospital
      • Guangzhou, Guangdong, China
        • Nanfang Hospital，Southern Medical University
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Guangzhou, Guangdong, China
        • The Affiliated TCM Hospital of Guangzhou Medical University
      • Zhongshan, Guangdong, China
        • Zhong Shan Hospital of Chinese Medicine
    • Guangxi
      • Nanning, Guangxi, China
        • Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
    • Henan
      • Luoyang, Henan, China
        • Luoyang Third People's Hospital
      • Nanyang, Henan, China
        • The First Affiliated Hospital of Nanyang Medical College
      • Zhengzhou, Henan, China
        • Pepole's Hospital of Xinzheng
    • Hunan
      • Changsha, Hunan, China
        • Hunan University of Chinese Medicine
      • Hengyang, Hunan, China
        • The First Affiliated Hospital of University of South China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Hospital of Traditional Chinese Medicine
    • Liaoning
      • Shenyang, Liaoning, China
        • The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xi'an Daxing Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
    • Tianjin
      • Tianjin, Tianjin, China
        • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Conformed to the diagnostic criteria of CHD and chronic heart failure
  • Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
  • Male or female subjects aged ≥ 40 years and ≤80 years
  • LVEF<45%(modified Simpson method)
  • NYHAⅡ-Ⅲ
  • Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks without adjustment of dose
  • Ability to understand the requirements of the study and willingness to provide written informed consent
  • Have no pregnancy program and take effective contraceptive measures voluntarily
  • Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment

Exclusion Criteria:

  • Patients with heart failure caused by other heart diseases,such as cor pulmonale, congenital heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, severe stenosis or insufficiency of heart valves, cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate massive pericardial effusion, constrictive pericarditis, infective endocarditis
  • Heart failure caused by systemic diseases or other systemic diseases, such as rheumatic immune and secretory diseases;heart failure caused by kidney disease, lung disease, liver disease and serious infection;heart failure caused by chemical or toxicological causes
  • Patients who had acute myocardial infarction, underwent coronary revascularization or left ventricular remodeling, underwent cardiac resynchronization with pacemaker implantation, underwent cardiothoracic surgery within 3 months prior to receiving the experimental drug, patients with other acute coronary syndrome, pulmonary embolism or acute cerebrovascular disease
  • Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or above sinus atrial or atrioventricular block without pacemaker treatment, average QTc > 500ms, heart rate < 50 beats/min, etc
  • Complicated with other serious diseases, such as pheochromocytoma, hematologic diseases, organ transplantation patients, and any history of malignant tumor
  • The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg
  • Hypotension with a systolic blood pressure <80mmHg and/or a diastolic blood pressure <50mmHg
  • Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit of normal, and/or estimated glomerular filtration rate (EGFR) <30 mL /min/1.73m2
  • HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L
  • Moderate and severe anemia (Hb < 90g/L)
  • Serum potassium ≥5.5mmol/L
  • Patients requiring anticoagulants who did not achieve dose stabilization for 1 month or INR > 3.0
  • In patients who need to take antiplatelet drugs, the dose was stable for less than 1 month, and the platelet value was lower than the lower limit of normal value
  • Allergic to the test drug or its related taste or ingredients
  • People with complicated mental illness, poor condition control and drug addiction
  • Unable to complete 6MWT
  • Pregnant or lactating women
  • Participation in other studies and use of investigational drugs from other studies within 3 months prior to screening
  • The investigator deems that the patient is not suitable to participate in the study, including the investigator's judgment that the patient is unable to complete the study or comply with the requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low dose group
Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Drug: Low dose QiShen YiQi Dripping Pills 3 bags
Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Other Names:
  • Low dose group
Experimental: High dose group
High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Drug: High dose QiShen YiQi Dripping Pills 3 bags
High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
Other Names:
  • High dose group
Placebo Comparator: Placebo group
QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
Drug: QiShen YiQi Dripping Pills placebo 3 bags
QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Other Names:
  • Placebo group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-Minutes-Walking-Test (6MWT) in week 12
Time Frame: Baseline to weeks 12
Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Baseline to weeks 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-Minutes-Walking-Test (6MWT) in weeks 4 and 8
Time Frame: Baseline to weeks 4 and 8
Change from baseline to weeks 4 and 8 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Baseline to weeks 4 and 8
NYHA classification
Time Frame: Baseline to weeks 4,8 and 12
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
Baseline to weeks 4,8 and 12
Traditional Chinese Medicine Syndrome Score
Time Frame: Baseline to weeks 4,8 and 12
Change from baseline to weeks 4,8 and 12 in Traditional Chinese Medicine Syndrome Score. There were 3 clinical primary symptoms, 4 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms scored as without 0, light 2, medium 4, heavy 6 points. The standard of TCM secondary symptoms scored as without 0, with 1 points. Tongue picture and pulse condition did not count.
Baseline to weeks 4,8 and 12
Dyspnea, weakness, edema
Time Frame: Baseline to weeks 4,8 and 12
Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.
Baseline to weeks 4,8 and 12
Echocardiogram results
Time Frame: Baseline to weeks 4,8 and 12
  1. Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography;
  2. Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography;
  3. Change from baseline to weeks 4,8 and 12 in left ventricular end systolic volume(LVESV) measured by echocardiography;
  4. Change from baseline to weeks 4,8 and 12 in left ventricular ejection fraction(LVEF) measured by echocardiography;
  5. Change from baseline to weeks 4,8 and 12 in stroke volume(SV) measured by echocardiography;
  6. Change from baseline to weeks 4,8 and 12 in cardiac output(CO) measured by echocardiography.
Baseline to weeks 4,8 and 12
NT-proBNP
Time Frame: Baseline to weeks 4,8 and 12
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Baseline to weeks 4,8 and 12
Minnesota Living With Heart Failure Questionnaire(MLHFQ)
Time Frame: Baseline to weeks 4,8 and 12
Change from baseline to weeks 4,8 and 12 in Minnesota Living With Heart Failure Questionnaire(MLHFQ). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items representing different degrees of impact of HF on health-related quality of life. Every item in this questionnaire scores from 0 (none) to 5 (very much) and the total items score from 0 (none) to 105 (very much).
Baseline to weeks 4,8 and 12
Cardiovascular adverse events
Time Frame: Week 12
To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.
Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Saturation of Peripheral Oxygen
Time Frame: Week 12
To determine whether the saturation of peripheral oxygen is improved from baseline to week 12 after treatment.
Week 12
Grasp strength body mass index test
Time Frame: Week 12
To determine whether the grasp strength body mass index is improved from baseline to week 12 after treatment.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSL-TCM-QSYQDW-HFrEF-Ⅱ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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