Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Abstract Background Heart failure with preserved ejection fraction (HFpEF) is a multifaceted clinical condition that comprises nearly 50% of all heart failure cases, making it a significant clinical challenge. Qishen granule (QSG) is a promising traditional Chinese medicine (TCM) treatment that show...
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BMC
2025-08-01
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| Series: | BMC Complementary Medicine and Therapies |
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| Online Access: | https://doi.org/10.1186/s12906-025-05029-z |
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| author | Huiqi Chen Zhibo Li Meiyi Su Guanghui Song Sien Guo Wenwei Feng Wensheng Chen Chun Li Lei Wang Wei Wang |
| author_facet | Huiqi Chen Zhibo Li Meiyi Su Guanghui Song Sien Guo Wenwei Feng Wensheng Chen Chun Li Lei Wang Wei Wang |
| author_sort | Huiqi Chen |
| collection | DOAJ |
| description | Abstract Background Heart failure with preserved ejection fraction (HFpEF) is a multifaceted clinical condition that comprises nearly 50% of all heart failure cases, making it a significant clinical challenge. Qishen granule (QSG) is a promising traditional Chinese medicine (TCM) treatment that shows cardioprotective potential against chronic heart failure, as evidenced in previous studies. This trial intends to perform a prospective clinical study to observe the efficacy and safety of QSG on HFpEF. Methods This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. Eighty eligible participants with HFpEF will be enrolled and randomly assigned in a 1:1 ratio and receive either the QSG treatment or placebo for 12 weeks, with all participants maintaining guideline-directed HFpEF therapy throughout the study period. The primary outcomes are changes in peak VO2 measured by cardiopulmonary exercise testing (CPET), and plasma NT-proBNP level from baseline to endpoint. Secondary outcomes include changes in echocardiography parameters, serum soluble human growth stimulation expressed gene 2 (ST2) protein levels, TCM syndrome integral scale score, quality of life and other indicators in CPET. Safety indicators like blood tests of liver and renal function and adverse events are used to assess the safety of QSG. Discussion This study’s result may establish clinical evidence supporting QSG’s therapeutic benefits and safety in HFpEF management. Trial registration https://clinicaltrials.gov/ . Registration number: NCT06377761. Registered on 2 June 2022. |
| format | Article |
| id | doaj-art-2eef5a8443024b09be01de33bf71daa8 |
| institution | Kabale University |
| issn | 2662-7671 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-2eef5a8443024b09be01de33bf71daa82025-08-20T03:42:37ZengBMCBMC Complementary Medicine and Therapies2662-76712025-08-0125111010.1186/s12906-025-05029-zEfficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trialHuiqi Chen0Zhibo Li1Meiyi Su2Guanghui Song3Sien Guo4Wenwei Feng5Wensheng Chen6Chun Li7Lei Wang8Wei Wang9The Second Clinical Medical College, Guangzhou University of Chinese MedicineThe Second Clinical Medical College, Guangzhou University of Chinese MedicineThe Second Clinical Medical College, Guangzhou University of Chinese MedicineState Key Laboratory of Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese MedicineDepartment of Cardiovascular Medicine, Dongguan Hospital of Guangzhou University of Chinese MedicineDepartment of Cardiovascular Medicine, Dongguan Hospital of Guangzhou University of Chinese MedicineState Key Laboratory of Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese MedicineState Key Laboratory of Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese MedicineState Key Laboratory of Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese MedicineSchool of Traditional Chinese Medicine, Beijing University of Chinese MedicineAbstract Background Heart failure with preserved ejection fraction (HFpEF) is a multifaceted clinical condition that comprises nearly 50% of all heart failure cases, making it a significant clinical challenge. Qishen granule (QSG) is a promising traditional Chinese medicine (TCM) treatment that shows cardioprotective potential against chronic heart failure, as evidenced in previous studies. This trial intends to perform a prospective clinical study to observe the efficacy and safety of QSG on HFpEF. Methods This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. Eighty eligible participants with HFpEF will be enrolled and randomly assigned in a 1:1 ratio and receive either the QSG treatment or placebo for 12 weeks, with all participants maintaining guideline-directed HFpEF therapy throughout the study period. The primary outcomes are changes in peak VO2 measured by cardiopulmonary exercise testing (CPET), and plasma NT-proBNP level from baseline to endpoint. Secondary outcomes include changes in echocardiography parameters, serum soluble human growth stimulation expressed gene 2 (ST2) protein levels, TCM syndrome integral scale score, quality of life and other indicators in CPET. Safety indicators like blood tests of liver and renal function and adverse events are used to assess the safety of QSG. Discussion This study’s result may establish clinical evidence supporting QSG’s therapeutic benefits and safety in HFpEF management. Trial registration https://clinicaltrials.gov/ . Registration number: NCT06377761. Registered on 2 June 2022.https://doi.org/10.1186/s12906-025-05029-zHeart failure with preserved ejection fractionQishen granuleCardiopulmonary exercise testProtocolRandomized controlled trial |
| spellingShingle | Huiqi Chen Zhibo Li Meiyi Su Guanghui Song Sien Guo Wenwei Feng Wensheng Chen Chun Li Lei Wang Wei Wang Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial BMC Complementary Medicine and Therapies Heart failure with preserved ejection fraction Qishen granule Cardiopulmonary exercise test Protocol Randomized controlled trial |
| title | Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full | Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_fullStr | Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_short | Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial |
| title_sort | efficacy and safety of qishen granule for treating heart failure with preserved ejection fraction a study protocol for a multicenter randomized double blind placebo controlled trial |
| topic | Heart failure with preserved ejection fraction Qishen granule Cardiopulmonary exercise test Protocol Randomized controlled trial |
| url | https://doi.org/10.1186/s12906-025-05029-z |
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