Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure
CACT-IHF
1 other identifier
interventional
640
1 country
33
Brief Summary
CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into two groups (treatment and control group) by central randomization service. The treatment group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three times a day in addition to standardized western medications. Whereas the control group will be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in addition to standardized western medications. Efficacy indicators include primary indicator (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause death, emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function classification; Minnesota life quality scale; scores from the four traditional chinese medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride, high density cholesterol and low density cholesterol. Safety indicators include blood pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum electrolytes, electrocardiogram and adverse events. All of the patients will receive interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th, 12th month after recruitment. All patients will be followed up until the end of study (Refers to the 12th month of the last case recruited into the study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 20, 2013
March 1, 2013
1.5 years
February 29, 2012
March 19, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
6MWT distance
0 month
6MWT
3rd month
6MWT
6th month
Secondary Outcomes (8)
Composite endpoint
1st,3rd,6th,9th,12th month
Brain natriuretic peptide (BNP)
0,6th month
Echocardiography
0,6th month
Cardiothoracic Ratio(CR)
0,6th month
Cardiac function classification, NYHA
0,1st,3rd,6th,9th,12th month
- +3 more secondary outcomes
Study Arms (2)
Qishen Yiqi dripping pills dummy
PLACEBO COMPARATORQishen Yiqi Dripping Pills
EXPERIMENTALInterventions
One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
Eligibility Criteria
You may qualify if:
- Age 40 to 79
- Patients with ischemic heart failure：
- LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
- History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG);
- Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure;
- With or without dyspnea, fatigue and fluid retention (edema) etc.
- History of heart failure or present with heart failure symptoms for at least 3 months;
- New York Heart Association (NYHA) Class II to IV;
- Submitted informed consent
You may not qualify if:
- Acute heart failure or acute exacerbation of chronic heart failure
- Those who have one of the following diseases:
- Acute coronary syndrome within 30 days
- Revascularization therapy within 6 months
- Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg
- Second degree type 2 or worse sinoatrial/atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia
- Dilated cardiomyopathy
- Hypertrophic obstructive cardiomyopathy
- Myocarditis
- Pulmonary artery embolism
- Severe valvular heart disease
- Pulmonary heart disease
- Stroke within 6 months
- Cardiac resynchronization therapy
- Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Guangdong Provincial Hospital of TCM
Guangdong, Guangdong, China
Second Affiliated Hospital of TCM College Guiyang
Guiyang, Guizhou, China
252 Hospital of Chinese People's Liberation Army
Baoding, Hebei, China
The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University
Heilongjiang, Heilongjiang, China
The First Affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
The Affiliated Nanhua Hospital of Nanhua University
Hengyang, Hunan, China
Jiangsu Province Traditional Chinese Medicine Hospital
Nanjing, Jiangsu, China
Nanjing Hospital of T.C.M
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangxi University of TCM
Nanchang, Jiangxi, China
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Shandong Province Traditional Chinese Medicine University Affiliated Hospital
Shandong, Shandong, China
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China
Shanghai Shuguang Hospital
Shanghai, Shanghai Municipality, China
Traditional Chinese Medicine Hospital of Shan Xi Province
Taiyuan, Shanxi, China
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Affiliated Hospital of Medical College of Chinese People's Armed Police Forces
Tianjin, Tianjin Municipality, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Second Affiliated Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, China
The 2nd Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tian Jin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affliated Hospital
Tianjin, Tianjin Municipality, China
Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Anhui University of TCM
Anhui, China
Dong Fang Hospital
Beijing, China
Related Publications (2)
Zhou Z, Wang S, Du Y, Zhao Z, Bi Y, Su Q, Hou Y, Wang X, Mao J. Effect of Qishen Yiqi Dripping Pill on Clinical Outcomes in Patients with Ischemic Heart Failure: A Post-Hoc Analysis of the CACT-IHF Randomized Trial. Drug Des Devel Ther. 2025 Nov 15;19:10163-10174. doi: 10.2147/DDDT.S556373. eCollection 2025.
PMID: 41268060DERIVEDHou YZ, Wang S, Zhao ZQ, Wang XL, Li B, Soh SB, Mao JY. Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF). Trials. 2013 May 14;14:138. doi: 10.1186/1745-6215-14-138.
PMID: 23672353DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jingyuan Mao, Dr.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 15, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
March 20, 2013
Record last verified: 2013-03