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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-09-17

Brief Summary

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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.

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Detailed Description

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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\&#39;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.

Conditions

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Heart Failure, Diastolic (HFpEF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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.

Group Type ACTIVE_COMPARATOR

Conventional heart failure treatment

Intervention Type DRUG

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.

intervention group

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.

Group Type ACTIVE_COMPARATOR

Pogejiuxin decoction combined with conventional heart failure treatment

Intervention Type DRUG

In addition to receiving standard heart failure treatment, patients are also administered Pogejiuxin Decoction.The formula of Pogejiuxin Decoction 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.

Interventions

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Conventional heart failure treatment

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.

Intervention Type DRUG

Pogejiuxin decoction combined with conventional heart failure treatment

In addition to receiving standard heart failure treatment, patients are also administered Pogejiuxin Decoction.The formula of Pogejiuxin Decoction 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.

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No