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Chronic Heart Failure With Reduced Ejection FractionPhase 2NCT04983043

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

A Phase 2 study testing Low dose QiShen YiQi Dripping Pills 3 bags and High dose QiShen YiQi Dripping Pills 3 bags in people with Chronic Heart Failure With Reduced Ejection Fraction, run by Tasly Pharmaceutical Group Co., Ltd at 23 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Low dose QiShen YiQi Dripping Pills 3 bags and High dose QiShen YiQi Dripping Pills 3 bags
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
23 sitesChina
Study dates
13 Jul 2021to 27 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

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

    Beijing, Beijing Municipality

  • Hunan University of Chinese Medicine

    Changsha, Hunan

  • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan

  • Dongguan TCM Hospital

    Dongguan, Guangdong

  • Nanfang Hospital，Southern Medical University

    Guangzhou, Guangdong

  • The Affiliated TCM Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang

  • Hefei First People's Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan

  • The First Hospital of ANHUI University of Science & Technology

    Huainan, Anhui

  • Luoyang Third People's Hospital

    Luoyang, Henan

  • Nanjing Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu

  • Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine

    Nanning, Guangxi

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan

  • The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

  • Suzhou Municipal Hospital

    Suzhou, Anhui

  • The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine

    Tianjin, Tianjin Municipality

  • Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang

  • Xi'an Daxing Hospital

    Xi'an, Shaanxi

  • Xiamen Hospital of Traditional Chinese Medicine

    Xiamen, Fujian

  • Pepole's Hospital of Xinzheng

    Zhengzhou, Henan

  • Zhong Shan Hospital of Chinese Medicine

    Zhongshan, Guangdong

Other trials in China

About this study

Official title: 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).

Read the 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).

Being tested
Low dose QiShen YiQi Dripping Pills 3 bags, High dose QiShen YiQi Dripping Pills 3 bags, QiShen YiQi Dripping Pills placebo 3 bags

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose QiShen YiQi Dripping Pills 3 bagsDrug

    Also called Low dose group

    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

  • High dose QiShen YiQi Dripping Pills 3 bagsDrug

    Also called High dose group

    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

  • QiShen YiQi Dripping Pills placebo 3 bagsDrug

    Also called Placebo group

    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

Study groups in NCT04983043
Study groupRoleWhat they receive
Low dose groupExperimentalLow dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Receives: Drug: Low dose QiShen YiQi Dripping Pills 3 bags
High dose groupExperimentalHigh dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Receives: Drug: High dose QiShen YiQi Dripping Pills 3 bags
Placebo groupPlacebo comparatorQiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
Receives: Drug: QiShen YiQi Dripping Pills placebo 3 bags

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-Minutes-Walking-Test (6MWT) in week 12

    Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.

    Measured: Baseline to weeks 12

Secondary outcomes (8)

  1. 6-Minutes-Walking-Test (6MWT) in 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.

    Measured: Baseline to weeks 4 and 8

  2. NYHA classification

    Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.

    Measured: Baseline to weeks 4,8 and 12

  3. Traditional Chinese Medicine Syndrome Score

    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.

    Measured: Baseline to weeks 4,8 and 12

  4. Dyspnea, weakness, edema

    Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.

    Measured: Baseline to weeks 4,8 and 12

  5. Echocardiogram results

    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.

    Measured: Baseline to weeks 4,8 and 12

  6. NT-proBNP

    Change from baseline to weeks 4,8 and 12 in NT-proBNP.

    Measured: Baseline to weeks 4,8 and 12

  7. Minnesota Living With Heart Failure Questionnaire(MLHFQ)

    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).

    Measured: Baseline to weeks 4,8 and 12

  8. Cardiovascular adverse events

    To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start13 Jul 2021
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983043
Sponsor's protocol ID
TSL-TCM-QSYQDW-HFrEF-Ⅱ
Status last verified
Mar 2024
First submitted
8 Jul 2021
Last updated
23 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • He X, Jiang Y, Li S, Liu D, Li Z, Han X, Zhang X, Dong X, Liu H, Huang J, Wang X, Long W, Ni S, Yang Z, Ye T. Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial. Int J Gen Med. 2023 Dec 28;16:6177-6188. doi: 10.2147/IJGM.S436999. eCollection 2023.

    PubMed 38169574

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose QiShen YiQi Dripping Pills 3 bags and High dose QiShen YiQi Dripping Pills 3 bags in people with Chronic Heart Failure With Reduced Ejection Fraction, run by Tasly Pharmaceutical Group Co., Ltd at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Minutes-Walking-Test (6MWT) in week 12 (time frame: Baseline to weeks 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983043, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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