Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure
NCT ID: NCT04983043
Last Updated: 2025-01-10
Study Results
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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COMPLETED
PHASE2
228 participants
INTERVENTIONAL
2021-06-10
2024-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose group
Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
Low dose QiShen YiQi Dripping Pills 3 bags
Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
High dose group
High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day
High dose QiShen YiQi Dripping Pills 3 bags
High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
Placebo group
QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
QiShen YiQi Dripping Pills placebo 3 bags
QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Interventions
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Low dose QiShen YiQi Dripping Pills 3 bags
Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
High dose QiShen YiQi Dripping Pills 3 bags
High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
QiShen YiQi Dripping Pills placebo 3 bags
QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
* Male or female subjects aged ≥ 40 years and ≤80 years
* LVEF\<45%(modified Simpson method)
* NYHAⅡ-Ⅲ
* Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks without adjustment of dose
* Ability to understand the requirements of the study and willingness to provide written informed consent
* Have no pregnancy program and take effective contraceptive measures voluntarily
* Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment
Exclusion Criteria
* Heart failure caused by systemic diseases or other systemic diseases, such as rheumatic immune and secretory diseases;heart failure caused by kidney disease, lung disease, liver disease and serious infection;heart failure caused by chemical or toxicological causes
* Patients who had acute myocardial infarction, underwent coronary revascularization or left ventricular remodeling, underwent cardiac resynchronization with pacemaker implantation, underwent cardiothoracic surgery within 3 months prior to receiving the experimental drug, patients with other acute coronary syndrome, pulmonary embolism or acute cerebrovascular disease
* Severe arrhythmias such as ventricular tachycardia, second degree Ⅱ type or above sinus atrial or atrioventricular block without pacemaker treatment, average QTc \> 500ms, heart rate \< 50 beats/min, etc
* Complicated with other serious diseases, such as pheochromocytoma, hematologic diseases, organ transplantation patients, and any history of malignant tumor
* The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg
* Hypotension with a systolic blood pressure \<80mmHg and/or a diastolic blood pressure \<50mmHg
* Patients with hepatic and/or renal dysfunction (ALT≥ 2 times the upper limit of normal, and/or estimated glomerular filtration rate (EGFR) \<30 mL /min/1.73m2
* HbA1c ≥9.0%, or fasting blood glucose ≥13.9mmol/L
* Moderate and severe anemia (Hb \< 90g/L)
* Serum potassium ≥5.5mmol/L
* Patients requiring anticoagulants who did not achieve dose stabilization for 1 month or INR \> 3.0
* In patients who need to take antiplatelet drugs, the dose was stable for less than 1 month, and the platelet value was lower than the lower limit of normal value
* Allergic to the test drug or its related taste or ingredients
* People with complicated mental illness, poor condition control and drug addiction
* Unable to complete 6MWT
* Pregnant or lactating women
* Participation in other studies and use of investigational drugs from other studies within 3 months prior to screening
* The investigator deems that the patient is not suitable to participate in the study, including the investigator's judgment that the patient is unable to complete the study or comply with the requirements of the study
40 Years
80 Years
ALL
No
Sponsors
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Tasly Pharmaceutical Group Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Hefei First People's Hospital
Hefei, Anhui, China
The First Hospital of ANHUI University of Science & Technology
Huainan, Anhui, China
Suzhou Municipal Hospital
Suzhou, Anhui, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Dongguan TCM Hospital
Dongguan, Guangdong, China
Nanfang Hospital，Southern Medical University
Guangzhou, Guangdong, China
The Affiliated TCM Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Zhong Shan Hospital of Chinese Medicine
Zhongshan, Guangdong, China
Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi, China
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
Luoyang Third People's Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Pepole's Hospital of Xinzheng
Zhengzhou, Henan, China
Hunan University of Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Nanjing Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Xi'an Daxing Hospital
Xi'an, Shaanxi, China
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Countries
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References
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He X, Jiang Y, Li S, Liu D, Li Z, Han X, Zhang X, Dong X, Liu H, Huang J, Wang X, Long W, Ni S, Yang Z, Ye T. Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial. Int J Gen Med. 2023 Dec 28;16:6177-6188. doi: 10.2147/IJGM.S436999. eCollection 2023.
Other Identifiers
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TSL-TCM-QSYQDW-HFrEF-Ⅱ
Identifier Type: -
Identifier Source: org_study_id
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