Pogejiuxin Decoction Combination of Conventional Western Medicine for the Treatment of Heart Failure with Preserved Ejection Fraction

Chongqing Traditional Chinese Medicine Hospital

Status: Completed

Conditions: Heart Failure, Diastolic (HFpEF)

Treatments: Drug: Conventional heart failure treatment; Drug: Pogejiuxin decoction combined with conventional heart failure treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06629246

2021-ky-17

Details and patient eligibility

About

The objective of this study is to investigate the potential of Pogejiuxin Decoction to enhance the efficacy and mitigate the adverse effects associated with conventional treatment in patients with heart failure and preserved ejection fraction(HFpEF), thereby establishing a foundation for its clinical application in managing HFpEF.

Full description

This study recruits patients with heart failure and preserved ejection fraction(HFpEF), randomly assigning them to either the intervention group or the control group. The control group will receive the standard heart failure treatment protocol, while the intervention group will take Pogejiuxin Decoction orally in addition to the control group's treatment. The study will compare the degree of symptom improvement, relevant auxiliary examination indicators, traditional Chinese medicine syndrome scores, and adverse reaction differences between the two groups, providing a clinical basis for the further enhancement of HFpEF treatment with the combination of Pogejiuxin Decoction and conventional therapy.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Inpatients with heart failure who meet the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Heart Failure 2018 and have grade II-IV heart function;
2. Inpatients who meet the diagnostic criteria for heart failure in TCM Internal Medicine(2012 edition);
3. Patients who meet the diagnostic criteria for HfpEF by heart color ultrasound;
4. Patients who sign informed consent and take the test voluntarily.

Exclusion criteria

1. Patients who do not meet the inclusion criteria.
2. Patients with severe hepatic or renal impairment (ALT/AST > 3 times the upper limit or serum creatinine levels > 265 umol/L or serum potassium > 5.5 mmol/L).
3. Patients with severe cerebrovascular, hematological, neurological diseases, or malignant tumors that require special treatment during the study period and may affect the judgment of heart failure treatment efficacy.
4. Patients with severe pneumonia, serious infections, or acute exacerbation of chronic obstructive pulmonary disease.
5. Pregnant or nursing women.
6. Patients with psychiatric abnormalities or unwilling to cooperate.
7. Patients allergic to the components of Pogejiuxin Decoction.
8. Patients undergoing coronary intervention, cardiac pacemaker implantation, placement of cardiac assist devices, or other treatments during the trial period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

control group

Active Comparator group

Description:

The control group will receive conventional heart failure treatment, which may include pharmacological therapies such as diuretics, ACE inhibitors/ARBs, beta-blockers, or aldosterone receptor antagonists, based on the clinical requirements of the condition, for a treatment period of 7 days.

Treatment:

Drug: Conventional heart failure treatment

intervention group

Active Comparator group

Description:

The intervention group will receive Pogejiuxin Decoction orally, in addition to the treatment protocol given to the control group.The specific medicinal formula is as follows: Processed Aconite 60g (decocted initially for 1 hour), Dried Ginger 60g, Honey-fried Licorice 60g, Cornus officinalis 60g, Ginseng 30g (decocted separately), Raw Dragon Bone 30g (decocted initially for 1 hour), Raw Oyster Shell 30g (decocted initially for 1 hour), Living Magnetite 30g, for a total of 7 prescriptions. Usage: Uniformly decocted with a herbal medicine decoction machine to obtain the medicinal liquid, one prescription per day, taken twice daily in the morning and evening, each time 100ml, for a continuous treatment of 7 days.

Treatment:

Drug: Pogejiuxin decoction combined with conventional heart failure treatment