Heart FailurePhase 4SHINE-HFNCT05583773
SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction
A Phase 4 study testing ShengXian-QuYu Decoction in people with Heart Failure, run by China-Japan Friendship Hospital at 26 sites in China.
Trial summary
The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- ShengXian-QuYu Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 26 sitesChina
- Study dates
- 29 Mar 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years at the time of consent.
- Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
- LVEF <50%.
- NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
- Provision of signed informed consent prior to any study specific procedures.
Who cannot join
- Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
- Uncontrolled severe arrhythmia.
- Planned to undergo heart transplantation or device implantation.
- Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment).
- Severe infection.
- eGFR <30 mL/min/1.73 m^2 by CKD-EPI.
Show all 13Show fewer
- Active malignancy requiring treatment at the time of visit 1.
- Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
- Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
- Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
- Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
- Participation in another clinical study.
- Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
China26 sites, 26 recruiting
- Recruiting
Tang County Hospital of Traditional Chinese Medicine
Baoding, Hebei, 072350
Jianfei Guan, +86 13483208655, 75821843@qq.com
Jianfei Guan
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Jiang Liu, +86 19800361320, yzliujiang@163.com
Jingyi Ren
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Ding Li, +86 18613818585, liding@pkuph.edu.cn
Ding Li
- Recruiting
Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, 100072
Lingling Liu, +86 18801200210, 329419791@qq.com
Lingling Liu
- Recruiting
Dongcheng District First People's Hospital
Beijing, Beijing Municipality, 100077
Hongyu Fu, +86 13260171971, 66232066@qq.com
Hongyu Fu
- Recruiting
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078
Xiaoyun Cui, +86 13811890290, you6171@126.com
Xiaoyun Cui
- Recruiting
Huairou District Traditional Chinese Medicine Hospital of Beijing
Beijing, Beijing Municipality, 101400
Shaojun Chen, +86 13552301395, 18910842603@163.com
Shaojun Chen
- Recruiting
Beijing Changping Nankou Hospital
Beijing, Beijing Municipality, 102202
Liling Zheng, +86 13260171971, 66232066@qq.com
Liling Zheng
- Recruiting
Changping District Traditional Chinese Medicine Hospital
Beijing, Beijing Municipality, 102208
Zhao Jin, +86 13426113311, singledouya@163.com
Zhao Jin
- Recruiting
Changji Hospital of Traditional Chinese Medicine
Changji, Xinjiang Uygur Autonomous Region, 831199
Liang Gui, +86 13999559026, xjguiliang@163.com
Liang Gui
- Recruiting
The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine
Changzhi, Shanxi, 046000
Haijun Song, +86 15534566561, 1549916295@qq.com
Haijun Song
- Recruiting
Changzhi Medical College Affiliated Heji Hospital
Changzhi, Shanxi, 046011
Xiaojian Liu, +86 18035590665, 787875739@qq.com
Xiaojian Liu
- Recruiting
Changzhi Hospital of Traditional Chinese Medicine
Changzhi, Shanxi, 046099
Meiling Shi, +86 13593286922, czzyytnbsml1606@163.com
Meiling Shi
- Recruiting
Chengdu Integrated TCM and Western Medicine Hospital
Chengdu, Sichuan, 610095
Yao Liu, +86 18011390008, 152101920@qq.com
Yao Liu
- Recruiting
Gongyi City Public Hospital of TCM
Gongyi, Henan, 451200
Jijie Wang, +86 13838199975, 393190024@qq.com
Feijiao Huo
- Recruiting
Jining Hospital of Traditional Chinese Medicine
Jining, Shandong, 272004
Zhiyang Zhu, +86 18753768269, zhuzhiyang136@126.com
Zhiyang Zhu
- Recruiting
Korla Hospital of Traditional Chinese Medicine
Korla, Xinjiang Uygur Autonomous Region, 841009
Huiyun Li, +86 13999014088, 623966191@qq.com
Huiyun Li
- Recruiting
Linhai Hospital of Traditional Chinese Medicine
Linhai, Zhejiang, 317000
Yingjing Song, +86 13646769521, hyysyj@126.com
Yingjing Song
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071
Hui Xin, +86 18661801287, xinhuiqy@163.com
Hui Xin
- Recruiting
Funing Hospital of Traditional Chinese Medicine
Qinhuangdao, Hebei, 066399
Shi Li, +86 13001422602, 358743873@qq.com
Shi Li
- Recruiting
Jixian Chinese Traditional Hospital
Tianjin, Tianjin Municipality, 301900
Baolong Yang, +86 13752702312, 176121179@qq.com
Baolong Yang
- Recruiting
Urumqi Hospital of Traditional Chinese Medicine
Ürümqi, Xinjiang, 830000
Palidan Wubu'er, +86 13999838082, 767829146@163.com
Palidan Wubu'er
- Recruiting
Xinyuan Traditional Chinese Medicine Hospital
Xinyuan, Xinjiang Uygur Autonomous Region, 835899
Weisheng Mao, +86 18935772083, 2717492525@qq.com
Weisheng Mao
- Recruiting
Yangzhou Hospital of Traditional Chinese Medicine
Yangzhou, Jiangsu, 225127
Xiaobin Wang, +86 18061178158, 2336905303@qq.com
Xiaobin Wang
- Recruiting
Gulja Hospital of Traditional Chinese Medicine
Yining, Xinjiang Uygur Autonomous Region, 835199
Zhiyang Zhang, +86 13999576733, 985104516@qq.com
Zhiying Zhang
- Recruiting
Zhaosu Hospital of Traditional Chinese Medicine
Zhaosu, Xinjiang Uygur Autonomous Region, 835699
Chao Zhang, +86 15739035725, 1554306702@qq.com
Chao Zhang
About this study
Official title: Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.
Read the detailed description
This is a pragmatic, nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with heart failure with reduced and mildly ejection fraction, evaluating the effect of "ShengXian-QuYu Decoction" versus placebo, given twice daily in addition to background regional standard of care. The effect of "ShengXian-QuYu Decoction"on quality of life, symptoms and biomarkers will be evaluated.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, Traditional Chinese Medicine syndrome type, diabetes status, kidney function, left ventricular ejection fraction, natriuretic peptide, and additional co-morbidities, concomitant medications, and others.
- Conditions
- Heart Failure
- Being tested
- ShengXian-QuYu Decoction, Placebo
- Keywords
- ShengXian-QuYu Decoction, Heart failure with reduced ejection fraction, Heart failure with mildly reduced ejection fraction, Quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShengXian-QuYu DecoctionDrug
Specification: 30ml/bag, given twice daily, per oral use.
PlaceboOther
Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use.
| Study group | Role | What they receive |
|---|---|---|
| ShengXian-QuYu Decoction | Active comparator | Patients will be randomized 1:1 to either ShengXian-QuYu Decoction or placebo. "ShengXian-QuYu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Panax ginseng (Hongshen), 12g of Anemarrhena asphodeloides (Zhimu), 8g of Cimicifuga foetida (Shengma), 8g of Bupleurum chinense (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Sparganium stoloniferum (Sanleng), 9g of Curcuma phaeocaulis (Ezhu), 3g of Whitmania pigra (Shuizhi). Receives: Drug: ShengXian-QuYu Decoction |
| placebo | Placebo comparator | Placebo matching ShengXian-QuYu Decoction Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Measured: Up to 12 weeks
Secondary outcomes (9)
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Measured: Up to 12 weeks
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.
Measured: Up to 12 weeks
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Measured: Up to 12 weeks
Change in Left Ventricular Systolic Function
Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
Measured: Up to 12 weeks
Change in Left Ventricular End-Diastolic Diameter
Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Measured: Up to 12 weeks
Change in Left Ventricular End-Systolic Diameter
Change in left ventricular end-systolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Measured: Up to 12 weeks
Change in Estimated Glomerular Filtration Rate from Baseline
Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI equation.
Measured: Up to 12 weeks
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Measured: Up to 26 weeks
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start29 Mar 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ren, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583773
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-02-0102
- Acronym
- SHINE-HF
- Status last verified
- Nov 2026
- First submitted
- 8 Oct 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05583773
- Acronym / sponsor ID
- SHINE-HF / 2022-NHLHCRF-LX-02-0102
- Conditions
- Heart Failure
- Keywords
- ShengXian-QuYu Decoction, Heart failure with reduced ejection fraction, Heart failure with mildly reduced ejection fraction, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.
Detailed description
This is a pragmatic, nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with heart failure with reduced and mildly ejection fraction, evaluating the effect of "ShengXian-QuYu Decoction" versus placebo, given twice daily in addition to background regional standard of care. The effect of "ShengXian-QuYu Decoction"on quality of life, symptoms and biomarkers will be evaluated.
The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, Traditional Chinese Medicine syndrome type, diabetes status, kidney function, left ventricular ejection fraction, natriuretic peptide, and additional co-morbidities, concomitant medications, and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShengXian-QuYu Decoction | Active comparator | Drug: ShengXian-QuYu DecoctionPatients will be randomized 1:1 to either ShengXian-QuYu Decoction or placebo. "ShengXian-QuYu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Panax ginseng (Hongshen), 12g of Anemarrhena asphodeloides (Zhimu), 8g of Cimicifuga foetida (Shengma), 8g of Bupleurum chinense (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Sparganium stoloniferum (Sanleng), 9g of Curcuma phaeocaulis (Ezhu), 3g of Whitmania pigra (Shuizhi). |
| placebo | Placebo comparator | Other: PlaceboPlacebo matching ShengXian-QuYu Decoction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged ≥18 years at the time of consent.
- Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
- LVEF <50%.
- NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
- Provision of signed informed consent prior to any study specific procedures.
Key exclusion criteria (13 listed)
- Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
- Uncontrolled severe arrhythmia.
- Planned to undergo heart transplantation or device implantation.
- Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment).
- Severe infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShengXian-QuYu DecoctionSpecification: 30ml/bag, given twice daily, per oral use. | Drug | ShengXian-QuYu Decoction |
| PlaceboPlacebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use. | Other | placebo |
Primary outcome
Change From Baseline in the KCCQ Clinical Summary Score
Time frame: Up to 12 weeks
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
9 secondary outcomes
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Time frame: Up to 12 weeks
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance
Time frame: Up to 12 weeks
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: Up to 12 weeks
Change in Left Ventricular Systolic Function
Time frame: Up to 12 weeks
Change in Left Ventricular End-Diastolic Diameter
Time frame: Up to 12 weeks
Change in Left Ventricular End-Systolic Diameter
Time frame: Up to 12 weeks
Change in Estimated Glomerular Filtration Rate from Baseline
Time frame: Up to 12 weeks
Change From Baseline in the KCCQ Clinical Summary Score
Time frame: Up to 26 weeks
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Time frame: Up to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ShengXian-QuYu Decoction in people with Heart Failure, run by China-Japan Friendship Hospital at 26 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengxi Yang, Dr. (+86 15120049452, mxtezuka@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the KCCQ Clinical Summary Score (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.