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RecruitingPhase 4NCT05583773

SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor

China-Japan Friendship Hospital

Enrollment

336 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a traditional Chinese herbal formula called SHengXIaN-QuYu Decoction in people with heart failure where the heart's pumping function is reduced or mildly reduced. Researchers want to see if it improves heart function, symptoms, and quality of life alongside standard heart failure medications. **You may be eligible if...** - You are 18 or older - You have been diagnosed with symptomatic heart failure with reduced or mildly reduced ejection fraction (heart pumps less than 50% of blood per beat) - Your heart failure symptoms are moderate to severe (Class II–IV) - Your biomarker levels (BNP or NT-proBNP) confirm heart failure **You may NOT be eligible if...** - You are currently in an acute heart failure episode or were recently hospitalized for it - You recently had a heart attack, stroke, heart surgery, or a heart procedure - Your heart failure is caused by valvular disease or congenital heart disease - You have significant kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGShengXian-QuYu Decoction

Specification: 30ml/bag, given twice daily, per oral use.

OTHERPlacebo

Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use.

Locations(26)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, China

Dongcheng District First People's Hospital

Beijing, Beijing Municipality, China

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Huairou District Traditional Chinese Medicine Hospital of Beijing

Beijing, Beijing Municipality, China

Beijing Changping Nankou Hospital

Beijing, Beijing Municipality, China

Changping District Traditional Chinese Medicine Hospital

Beijing, Beijing Municipality, China

Tang County Hospital of Traditional Chinese Medicine

Baoding, Hebei, China

Funing Hospital of Traditional Chinese Medicine

Qinhuangdao, Hebei, China

Gongyi City Public Hospital of TCM

Gongyi, Henan, China

Yangzhou Hospital of Traditional Chinese Medicine

Yangzhou, Jiangsu, China

Jining Hospital of Traditional Chinese Medicine

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine

Changzhi, Shanxi, China

Changzhi Medical College Affiliated Heji Hospital

Changzhi, Shanxi, China

Changzhi Hospital of Traditional Chinese Medicine

Changzhi, Shanxi, China

Chengdu Integrated TCM and Western Medicine Hospital

Chengdu, Sichuan, China

Jixian Chinese Traditional Hospital

Tianjin, Tianjin Municipality, China

Urumqi Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, China

Korla Hospital of Traditional Chinese Medicine

Bayan Gol Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China

Changji Hospital of Traditional Chinese Medicine

Changji Hui Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China

Gulja Hospital of Traditional Chinese Medicine

Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China

Zhaosu Hospital of Traditional Chinese Medicine

Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China

Xinyuan Traditional Chinese Medicine Hospital

Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region, China

Linhai Hospital of Traditional Chinese Medicine

Linhai, Zhejiang, China

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NCT05583773

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