AzTrials
AzTrials

Chronic Heart FailurePhase 2NCT01939236

Traditional Chinese Medicine for Treatment of Chronic Heart Failure

A Phase 2 study testing traditional Chinese medicine in people with Chronic Heart Failure, run by Beijing University of Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether traditional Chinese medicine as complementary treatment is safe and effective in the treatment of chronic heart failure. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
traditional Chinese medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteChina
Study dates
May 2010to Sep 2012
Phase
Phase 2
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The basic primary heart disease is coronary heart disease ( with diagnosis for coronary heart disease : confirmed by coronary angiography; confirmed by coronary CT; history of acute myocardial infarction; limb-salvage Q wave for ECG; ecg ECG test and radionuclide examination support, etc.); no history of hypertension or taking antihypertensive drugs, with blood pressure under 160/100 mmHg.
  • With a history of coronary heart disease, symptoms and signs; with difficult breathing, fatigue and fluid retention (edema); with left ventricular enlargement, end systolic volume of left ventricular increase and left ventricular ejection fraction (LVEF) ≤ 40; with New York Heart Association (NYHA) functional classificationⅡ or Ⅲ.
  • Male or female subjects between 40 and 75 years old;

Who cannot join

  • Serious valvular heart disease, pericardial disease, cardiomyopathy, congenital heart disease, acute myocardial infarction ( within 4 weeks), cardiac shock, acute myocarditis or serious arrhythmia with the variation of hemodynamics.
  • Pulmonary artery hypertension caused by pulmonary heart disease, acute or chronic pulmonary embolism, or stroke within a half year.
  • Serious hepatic insufficiency ( the index of liver function being 2 times of normal one), renal insufficiency (Ccr>20%, Scr>3mg/dl or 265 μmol/L), diseases of blood system, malignant tumor, diabetes mellitus with serious complications, hyperthyroid or hypothyroid.
  • Infection: fever; the numeration of leukocyte being more than 10×109/L, the percentage of neutrophile granulocyte being more than 85%; patchy shadows in X ray of Chest, meeting one of the above three.
  • Pregnancy or lactation; mental disease and infectious disease patients.
  • Take part in other trials within two months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: Traditional Chinese Medicine for Treatment of Chronic Heart Failure: A Multicenter Randomized Double-blind Placebo-controlled Clinical Trial

The purpose of this study is to determine whether traditional Chinese medicine as complementary treatment is safe and effective in the treatment of chronic heart failure.

Read the detailed description

Heart failure (HF) can be defined as an abnormality of cardiac structure or function leading to failure of heart to deliver oxygen at a rate commensurate with the requirements of the metabolizing tissues, despite normal filling pressures (or only at the expense of increased filling pressures). And according to the nature of the clinical presentation, HF is divided into acute or chronic HF.

In 2003, a random sample survey of 15,518 urban or rural residents between 35 and 74 years old was made in China: the prevalence rate of heart failure was 0.9%, and according to the result, there was about 4,000,000 HF subjects in China.

In China, the integrative treatment of western and traditional Chinese medicine (TCM) for HF is common and has been developed as a treatment model. TCM has been used in China and other south and east Asia countries for thousands of years. Syndrome differentiation and treatment variation are the basic principles in understanding and treatment of diseases. Investigators would like to test the hypothesis that it is efficacy and safety for patients to take TCM granules according to syndrome differentiation.

The specific aims for the study were to evaluate the efficacy and safety of TCM in treating chronic heart failure (CHF).

Being tested
traditional Chinese medicine, Placebo (gummeline)
Keywords
chronic heart failure, traditional Chinese medicine, syndrome differentiation

What participants receive

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

  • traditional Chinese medicineDrug

    Also called Qi deficiency：huangqi, dangshen, Blood stasis: danshen, chishao,taoren, honghua, Water retention: zexie, zhuling, cheqianzi, tinglizi, Yang deficiency: rougui, zhifuzi

    1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28days.

  • Placebo (gummeline)Drug

    Also called Qi deficiency： gummeline, Blood stasis: gummeline, Water retention: gummeline, Yang deficiency: gummeline

    Placebo of each syndrome differentiation has the same weight and smell as traditional Chinese medicine of corresponding syndrome differentiation.

    1 bag of drug 2 times per day for 28 days according to syndrome differentiation.

    For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28 days.

Study groups in NCT01939236
Study groupRoleWhat they receive
traditional Chinese medicineExperimentalSubjects were treated with TCM 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient with chronic heart failure is qi deficiency and blood stasis. He will take drug of qi deficiency and blood stasis 2 times per day for 28 days.
Receives: Drug: traditional Chinese medicine
placebo (gummeline)Placebo comparatorSubjects were treated with placebo 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient with chronic heart failure is qi deficiency and blood stasis. He will take drug of qi deficiency and blood stasis 2 times per day for 28 days.
Receives: Drug: Placebo (gummeline)

What is being measured

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

  1. Left ventricular ejection fraction

    The level of left ventricular ejection fraction was detected with the modified Simpson's rule at baseline and 28 days.

    Measured: 14 days, 28 days

Secondary outcomes (3)

  1. Traditional Chinese medicine syndrome scores (TCM-SS)

    Before the study, all investigators took standardized training and conformance testing. Syndrome differentiation and syndrome scores were took by 3 investigators together, and the results needed to obtain two or more investigators' consent. There were 65 clinical symptoms evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM symptoms scored as without 0; very light 1; light 2; medium 3; heavy 4; very heavy 5 points.

    Measured: 14 days, 28 days

  2. New York Heart Association (NYHA) functional classification

    Measured: 14 days, 28 days

  3. 6-minute walk test (6MWT)

    6MWT was took according to the guidelines for the 6MWT promulgated by the American Thoracic Society at baseline and 28 days after treatment.

    Measured: 14 days, 28 days

Timeline

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

  1. First posted11 Sep 2013 (estimated)
  2. Study startMay 2010
  3. Primary completionAug 2012
  4. Study completionSep 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939236
Sponsor's protocol ID
BUCMlltllt1984
Status last verified
Oct 2013
First submitted
13 Aug 2013
Last updated
10 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Gao K, Zhao H, Gao J, Wen B, Jia C, Wang Z, Zhang F, Wang J, Xie H, Wang J, Wang W, Chen J. Mechanism of Chinese Medicine Herbs Effects on Chronic Heart Failure Based on Metabolic Profiling. Front Pharmacol. 2017 Nov 22;8:864. doi: 10.3389/fphar.2017.00864. eCollection 2017.

    PubMed 29213243

  • Luo L, Chen J, Guo S, Wang J, Gao K, Zhang P, Chen C, Zhao H, Wang W. Chinese Herbal Medicine in the Treatment of Chronic Heart Failure: Three-Stage Study Protocol for a Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:927160. doi: 10.1155/2015/927160. Epub 2015 May 18.

    PubMed 26089951

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing traditional Chinese medicine in people with Chronic Heart Failure, run by Beijing University of Chinese Medicine at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction (time frame: 14 days, 28 days). 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 NCT01939236, 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 10 Oct 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in