Health TrialsbyHealthPanel

Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-79
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Jia Shen Tablet Placebo

    Drug

    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 Tablet

    Drug

    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 Tablet

    Drug

    High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks

Treatment groups

288 Participants
are divided into 3 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Low dose groupExperimental treatment 1 intervention
Group C: High dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12.

Time frame
Baseline and Week 12.

Secondary outcomes

1

6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6.

Time frame
Baseline and Week 6.
2

NT-proBNP: the change from baseline to Week 6 and 12.

Time frame
Baseline, Week 6 and 12.
3

NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%.

Time frame
Baseline, Week 6 and 12.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tasly Pharmaceutical Group Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: