Trials / Completed
CompletedNCT04944706
Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction
Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction: a Randomized, Double-blind, Basic-treatment-loading, Placebo-controlled, Multicenter Phase Ⅱ Clinical Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 225 (actual)
- Sponsor
- Tasly Pharmaceutical Group Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction.
Detailed description
Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction. Exploratory research objective: To explore the changes of endogenous substances in vivo before and after drug administration, to interpret the mechanism of drug action through metabolomics and systems biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time | Take 3 times a day after meals,24 weeks |
| DRUG | Qishen Yiqi dripping pills 4 bags/time | Take 3 times a day after meals,24 weeks |
| DRUG | Qishen Yiqi dripping pills placebo 4 bags/time | Take 3 times a day after meals,24 weeks |
Timeline
- Start date
- 2021-07-27
- Primary completion
- 2024-12-19
- Completion
- 2024-12-19
- First posted
- 2021-06-30
- Last updated
- 2025-01-09
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04944706. Inclusion in this directory is not an endorsement.