Heart FailurePhase 2NCT06669169
Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure
A Phase 2 study testing Low dose Jia Shen Tablet and High dose Jia Shen Tablet in people with Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Low dose Jia Shen Tablet and High dose Jia Shen Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2025to 31 Dec 2026
- Phase
- Phase 2
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-79 years, either sex;
- Meet the diagnostic criteria for CHD and CHF;
- Meet the TCM differentiation criteria of yang qi deficiency and blood stasis in CHF;
- Class Ⅱ to Ⅲ for NYHA functional classification;
- Willing to provide written informed consent.
Who cannot join
- CHF with acute exacerbation or intravenous drug therapy;
- Received cardiac resynchronization therapy (CRT) or other heart failure devices;
- Within 3 months before randomization, acute coronary syndrome（ACS）, stroke or transient ischemic attack（TIA） occurred or received cardiac revascularization (PCI, CABG);
- Plan to undergo cardiac revascularization (PCI, CABG) or cardiac resynchronization therapy (CRT) during the trial period;
- Severe arrhythmias [such as persistent atrial fibrillation, permanent atrial fibrillation, ventricular tachycardia, second-degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) exceeding 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
- Severe hypertension (systolic blood pressure ≥180mm Hg or diastolic blood pressure ≥110mm Hg) or hypotension (systolic blood pressure < 90 mmHg);
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- Heart failure caused by other cardiovascular diseases such as congenital heart disease, severe stenosis or insufficiency of heart valves, cardiomyopathy (e.g. hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), moderate pericardial effusion, constrictive pericarditis, and infective endocarditis;
- Combined with liver, kidney, hematopoietic system and other serious primary diseases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times the upper limit of local laboratory normal value, the estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2, Blood potassium > 5.5 mmol/L or hemoglobin (Hb) < 90 g/L; Malignant tumors, severe neuroendocrine system diseases and mental diseases;
- Pregnant or lactating;
- Participating in other interventional clinical studies within 1 month before screening;
- Allergic constitution, or allergic to Chinese medicines of Jia Shen Tablets (such as Periploca sepium, salvia miltiorrhiza, etc.);
- The investigator determines that the patient is unable to complete the study or comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Tianjin University of traditional Chinese
Tianjin, Tianjin Municipality
Jingyuan Mao
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial：Efficacy and Safety of Jia Shen Tablets in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Qi Deficiency With Blood Stasis)
Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.
- Conditions
- Heart Failure
- Being tested
- Jia Shen Tablet Placebo, Low dose Jia Shen Tablet, High dose Jia Shen Tablet
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jia Shen Tablet PlaceboDrug
Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks
Low dose Jia Shen TabletDrug
Low dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks
High dose Jia Shen TabletDrug
High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Jia Shen Tablet Placebo |
| Low dose group | Experimental | Not described Receives: Drug: Low dose Jia Shen Tablet |
| High dose group | Experimental | Not described Receives: Drug: High dose Jia Shen Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12.
Measured: Baseline and Week 12.
Secondary outcomes (9)
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6.
Measured: Baseline and Week 6.
NT-proBNP: the change from baseline to Week 6 and 12.
Measured: Baseline, Week 6 and 12.
NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%.
Measured: Baseline, Week 6 and 12.
Echocardiogram: Measurements will be made of the left ventricle's end diastolic diameter (LVEDD), end diastolic volume (LVEDV), end systolic volume (LVESV), left ventricular ejection fraction（LVEF）, stroke volume (SV), and cardiac output (CO).
Measured: Baseline and Week 12.
NYHA functional classification: Measure the percentage of participants whose NYHA functional classification is improved/worsened/unchanged from baseline to Week 6 and 12.
Measured: Baseline, Week 6 and 12.
MLHFQ Score: the change from baseline to Week 6 and 12.
The MLHFQ consists of 21 elements representing varying degrees of impact of HF on health related quality of life. Each item in this questionnaire is scored from 0 (none) to 5 (very much), and the total item score is from 0 (none) to 105 (very much).
Measured: Baseline, Week 6 and 12.
Traditional Chinese Medicine（TCM） Syndrome Score: change from baseline to Week 6 and 12.
There were 3 primary symptoms and 4 secondary symptoms. The state of the tongue and pulse is used to evaluate and score TCM symptoms. 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, light 1, medium 2, heavy 3 points. Tongue picture and pulse condition did not count.
Measured: Baseline, Week 6 and 12.
Dyspnea, weakness and edema: the rate of disappearance of the symptoms (dyspnea, weakness, and edema) from baseline to Week 6 and 12.
Measured: Baseline, Week 6 and 12.
Cardiovascular Adverse Events: Incidence of Cardiovascular AEs（cardiovascular death, hospitalization for worsening heart failure, hospitalization for nonfatal myocardial infarction, hospitalization for nonfatal stroke）.
Measured: Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start31 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Tasly Pharmaceutical Group Co., LtdThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669169
- Sponsor's protocol ID
- TSL-TCM-JSP-Ⅱ
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial：Efficacy and Safety of Jia Shen Tablets in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Yang Qi Deficiency With Blood Stasis)
- ClinicalTrials.gov ID
- NCT06669169
- Acronym / sponsor ID
- TSL-TCM-JSP-Ⅱ
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Nov 2024 (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.
Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Jia Shen Tablet Placebo |
| Low dose group | Experimental | Drug: Low dose Jia Shen Tablet |
| High dose group | Experimental | Drug: High dose Jia Shen Tablet |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-79 years, either sex;
- Meet the diagnostic criteria for CHD and CHF;
- Meet the TCM differentiation criteria of yang qi deficiency and blood stasis in CHF;
- Class Ⅱ to Ⅲ for NYHA functional classification;
- Willing to provide written informed consent.
Key exclusion criteria (12 listed)
- CHF with acute exacerbation or intravenous drug therapy;
- Received cardiac resynchronization therapy (CRT) or other heart failure devices;
- Within 3 months before randomization, acute coronary syndrome（ACS）, stroke or transient ischemic attack（TIA） occurred or received cardiac revascularization (PCI, CABG);
- Plan to undergo cardiac revascularization (PCI, CABG) or cardiac resynchronization therapy (CRT) during the trial period;
- Severe arrhythmias [such as persistent atrial fibrillation, permanent atrial fibrillation, ventricular tachycardia, second-degree type II or higher sinus or atrioventricular block without pacemaker placement, QT interval (QTc) exceeding 480 ms after heart rate adjustment according to Fridericia's formula, or known history or symptoms of long QT syndrome];
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 |
|---|---|---|
| Jia Shen Tablet PlaceboJia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks | Drug | Placebo group |
| Low dose Jia Shen TabletLow dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks | Drug | Low dose group |
| High dose Jia Shen TabletHigh dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks | Drug | High dose group |
Primary outcome
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12.
Time frame: Baseline and Week 12.
9 secondary outcomes
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6.
Time frame: Baseline and Week 6.
NT-proBNP: the change from baseline to Week 6 and 12.
Time frame: Baseline, Week 6 and 12.
NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%.
Time frame: Baseline, Week 6 and 12.
Echocardiogram: Measurements will be made of the left ventricle's end diastolic diameter (LVEDD), end diastolic volume (LVEDV), end systolic volume (LVESV), left ventricular ejection fraction（LVEF）, stroke volume (SV), and cardiac output (CO).
Time frame: Baseline and Week 12.
NYHA functional classification: Measure the percentage of participants whose NYHA functional classification is improved/worsened/unchanged from baseline to Week 6 and 12.
Time frame: Baseline, Week 6 and 12.
MLHFQ Score: the change from baseline to Week 6 and 12.
Time frame: Baseline, Week 6 and 12.
Traditional Chinese Medicine（TCM） Syndrome Score: change from baseline to Week 6 and 12.
Time frame: Baseline, Week 6 and 12.
Dyspnea, weakness and edema: the rate of disappearance of the symptoms (dyspnea, weakness, and edema) from baseline to Week 6 and 12.
Time frame: Baseline, Week 6 and 12.
Cardiovascular Adverse Events: Incidence of Cardiovascular AEs（cardiovascular death, hospitalization for worsening heart failure, hospitalization for nonfatal myocardial infarction, hospitalization for nonfatal stroke）.
Time frame: Week 12.
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 1 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose Jia Shen Tablet and High dose Jia Shen Tablet in people with Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 1 site 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 12 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: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12. (time frame: Baseline and Week 12.). 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 1 Nov 2024.