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Ischemic Heart FailureCACT-IHFNCT01555320

Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure

A study testing Qishen Yiqi Dripping Pills and Qishen Yiqi dripping pills dummy in people with Ischemic Heart Failure, run by State Administration of Traditional Chinese Medicine of the People's Republic of China at 33 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 to 79 years
Conditions the study is for
Ischemic Heart Failure
What is being tested?
Qishen Yiqi Dripping Pills and Qishen Yiqi dripping pills dummy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
640 participants
Where
33 sitesChina
Study dates
Mar 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • Severe endocrine diseases such as hyperthyroidism, etc.
  • History of malignant tumor
  • Hemoglobin (HB )≤ 9g/dl
  • Alanine aminotransferase (ALT) > 2 times the upper limit of normal
  • Serum creatinine > 265 μmol/L
  • Mental disorder
  • Being pregnant, planning for pregnancy or breastfeeding
  • Suspicious or definite allergy to intervention drugs
  • Participated in other trials within 2 months
  • Unable to walk autonomously due to physical disabilities

Trial locations and contacts

33 sites in 1 country.

Yazhu Hou, Dr. contact

8622-27432325

mreleven@163.com

33 sites in 1 country

China33 sites, 33 recruiting
  • The First Affiliated Hospital of Anhui University of TCM

    Anhui

    Zhengbin Shao, Dr., shaozhengbin@126.com

    Xiaohua Dai, Dr.

    Recruiting
  • 252 Hospital of Chinese People's Liberation Army

    Baoding, Hebei

    Xuebin Cao, Dr., cxb13633227588@126.com

    Xuebin Cao, Dr.

    Recruiting
  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, Beijing Municipality

    Yao Han, Dr., Hanyao1212@126.com

    Hongxu Liu, Prof

    Recruiting
  • Fuwai Hospital

    Beijing, Beijing Municipality

    Bingqi Wei, Dr., weibing918q@sina.com

    Jian Zhang, Prof

    Recruiting
  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality

    Yang Miao, Dr., Miya9@163.com

    Yang Miao, Dr.

    Recruiting
  • Dong Fang Hospital

    Beijing

    Jinjin Lu, Dr., Lu2008jinjin@126.com

    Yang Wu, Dr.

    Recruiting
  • The Affiliated Hospital To Changchun University of Chinese Medicine

    Changchun, Jilin

    Yudan Tian, Dr., 30880356@qq.com

    Yue Deng, Dr.

    Recruiting
  • The First Hospital of Jilin University

    Changchun, Jilin

    Yaqiu Jiang, Dr., yaqiujiang@163.com

    Yaqiu Jiang, Dr.

    Recruiting
  • Teaching Hospital of Chengdu University of TCM

    Chengdu, Sichuan

    Li Jiang, Dr., cdwwx729@163.com

    Weixing Wang, Dr.

    Recruiting
  • Guangdong Provincial Hospital of TCM

    Guangdong, Guangdong

    Xiaogang Sheng, Dr., shengxiaogang1@sina.com.cn

    Huanlin Wu, Prof

    Recruiting
  • Second Affiliated Hospital of TCM College Guiyang

    Guiyang, Guizhou

    Tingchun Wu, Dr., 649164263@qq.com

    Tao Xu, Dr.

    Recruiting
  • The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University

    Heilongjiang, Heilongjiang

    Yan Wang, Dr., 19911737@qq.com

    Yang Li, Dr., 19911737@qq.com

    Recruiting
  • The Affiliated Nanhua Hospital of Nanhua University

    Hengyang, Hunan

    Huan Liu, Dr.

    Xiaofeng Ma, Dr.

    Recruiting
  • The Affiliated Hospital of Jiangxi University of TCM

    Nanchang, Jiangxi

    Peng Deng, Dr., dengpeng615@sina.com

    Zhongyong Liu, Dr.

    Recruiting
  • Jiangsu Province Traditional Chinese Medicine Hospital

    Nanjing, Jiangsu

    Bo Zhu, Dr., najahannah@sina.com

    Xiaohu Chen, Dr.

    Recruiting
  • Nanjing Hospital of T.C.M

    Nanjing, Jiangsu

    Zhongxing Shao, Dr., Szx790102@sohu.com

    Ning Gu, Dr.

    Recruiting
  • Shandong Province Traditional Chinese Medicine University Affiliated Hospital

    Shandong, Shandong

    Yunlun Li, Dr., liyunlun@163.com

    Yitao Xue

    Recruiting
  • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

    Shanghai, Shanghai Municipality

    Qingfen Zhou, Dr., zhouqingfen@hotmail.com

    Fengru Zhang, Dr.

    Recruiting
  • Shanghai Shuguang Hospital

    Shanghai, Shanghai Municipality

    Yongming Liu, Dr., liuyongming@foxmail.com

    Xiaolong Wang, Dr.

    Recruiting
  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

    Ying Yang, Dr., Yang_ying_2002@sina.com

    Fengrong Wang, Dr.

    Recruiting
  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Tao Ding, Dr., chensn@sj-hospital.org

    Suning Chen, Prof

    Recruiting
  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Haiyan Shan, Dr., shanhy024@163.com

    Xiaojuan Bai, Dr.

    Recruiting
  • The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

    Donghai Wang, Dr., fine_dongbo@163.com

    Bo Dong, Dr.

    Recruiting
  • Traditional Chinese Medicine Hospital of Shan Xi Province

    Taiyuan, Shanxi

    Tianfu Niu, Dr., niutianfu2584@sina.com

    Tianfu Niu, Dr.

    Recruiting
  • Affiliated Hospital of Medical College of Chinese People's Armed Police Forces

    Tianjin, Tianjin Municipality

    Jun Tian, Dr., Tianjun6666@hotmail.com

    Tiemin Jiang, Dr.

    Recruiting
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality

    Yazhu Hou, mreleven@163.com

    Jingyuan Mao, Dr.

    Recruiting
  • Second Affiliated Hospital of Tianjin University of TCM

    Tianjin, Tianjin Municipality

    Tao Wang, Dr., Wangtao973@163.com

    Yingqiang Zhao, Dr.

    Recruiting
  • The 2nd Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

    Ruyu Yuan, Dr., tjcardio@gmail.com

    Ruyu Yuan, Dr.

    Recruiting
  • Tian Jin Chest Hospital

    Tianjin, Tianjin Municipality

    Jie Geng, Dr., gengjie_1973@126.com

    Shutao Chen, Dr.

    Recruiting
  • Tianjin Academy of Traditional Chinese Medicine Affliated Hospital

    Tianjin, Tianjin Municipality

    Chuanhui Huang, Dr., huangchuanhui66@sina.com

    Ruihong Fan, Dr.

    Recruiting
  • Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region

    Ürümqi, Xinjiang

    Dongqing An, Dr., wxf87112008@163.com

    Xiaofeng Wang, Dr.

    Recruiting
  • Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi

    Jing Qi, 404317104@qq.com

    Yonggang Wang, Dr.

    Recruiting
  • The First Affiliated Hospital of Henan University of TCM

    Zhengzhou, Henan

    Tinghai Du, Dr., dth2010@163.com

    Mingjun Zhu, Dr.

    Recruiting

Other trials in China

About this study

Official title: Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure (CACT-IHF) A Randomized, Double-blind, Multicenter, Placebo-controlled Trial

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).

Being tested
Qishen Yiqi Dripping Pills, Qishen Yiqi dripping pills dummy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qishen Yiqi Dripping PillsDrug

    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.

  • Qishen Yiqi dripping pills dummyDrug

    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.

Study groups in NCT01555320
Study groupRoleWhat they receive
Qishen Yiqi dripping pills dummyPlacebo comparatorNot described
Receives: Drug: Qishen Yiqi dripping pills dummy
Qishen Yiqi Dripping PillsExperimentalNot described
Receives: Drug: Qishen Yiqi Dripping Pills

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6MWT distance

    Measured: 0 month

  2. 6MWT

    Measured: 3rd month

  3. 6MWT

    Measured: 6th month

Secondary outcomes (8)
  1. Composite endpoint

    all-cause death, frequency of 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.

    Measured: 1st,3rd,6th,9th,12th month

  2. Brain natriuretic peptide (BNP)

    Measured: 0,6th month

  3. Echocardiography

    Measured: 0,6th month

  4. Cardiothoracic Ratio(CR)

    Measured: 0,6th month

  5. Cardiac function classification, NYHA

    Measured: 0,1st,3rd,6th,9th,12th month

  6. Minnesota life quality scale

    Measured: 0,1st,3rd,6th,9th,12th month

  7. Scores from the four TCM diagnostic methods

    Measured: 0,1st,3rd,6th,9th,12th month

  8. blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG)

    Measured: 0,3rd,6thmonth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
640 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01555320
Sponsor's protocol ID
201007001-02
Acronym
CACT-IHF
Status last verified
Mar 2013
First submitted
29 Feb 2012
Last updated
20 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41268060
  • Hou 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.

    PubMed 23672353

Questions about this trial

What is this clinical trial studying?

A study testing Qishen Yiqi Dripping Pills and Qishen Yiqi dripping pills dummy in people with Ischemic Heart Failure, run by State Administration of Traditional Chinese Medicine of the People's Republic of China at 33 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yazhu Hou, Dr. (8622-27432325, mreleven@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6MWT distance (time frame: 0 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01555320, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.

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