Multi-center, randomized, double-blind, placebo parallel controlled evaluation Clinical Study on the efficacy and safety of Kuxin Pingni Granules in Treating Chronic Heart Failure

Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: Control group:Placebo: the appearance of comfort granules was exactly the same as the test drug. The drug ingredients containing the formulation agent and less than 5% of the above prescriptions are prepared into formula granule packaging with the same weight, color, smell, taste and package appearance.;test group:On the basis of standardized treatment of chronic heart failure, Kuxin Pingni formula Granules was added.; CONDITION: chronic heart failure PRIMARY OUTCOME: Echocardiogram;renal function;NT‐pro BNP;Minnesota Heart Failure Quality of Life Questionnaire;Heart function classification;6min walking distance;Blood fat; SECONDARY OUTCOME: Adverse Events;Chinese medicine symptom comple Xscore; INCLUSION CRITERIA: (1) It is consistent with the diagnosis of chronic heart failure in western medicine, and the history of chronic heart failure or clinical symptoms of heart failure have been found for more than 3 months; (2) The cardiac function was classified as grade II IV (NYHA), and chronic heart failure was in stages C and D; (3) The syndrome differentiation of traditional Chinese medicine is Qi and yin deficiency and internal stagnation of water and blood stasis; (4) Plasma NT proBNP was greater than 600 pg / ml, and plasma NT proBNP was greater than 900 pg / ml in heart failure complicated with atrial fibrillation or atrial flutter; (5) Those who have received the optimal drug treatment of fixed dose western medicine for at least 2 weeks and have not been given intravenous therapy with vasoactive drugs or diuretics; (6) Age 18‐85 years old, regardless of gender; (7) No traditional Chinese medicine for the treatment of heart failure was used within 2
Epistemonikos ID: 409909e4113175e0aa52b4fbeadbe5fbacb59fc7
First added on: Aug 26, 2024