NCT01939236

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

August 13, 2013

Last Update Submit

October 8, 2013

Conditions

Chronic Heart Failure

Keywords

chronic heart failuretraditional Chinese medicinesyndrome differentiation

Outcome Measures

Primary Outcomes (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.

    14 days, 28 days

Secondary Outcomes (3)

  • Traditional Chinese medicine syndrome scores (TCM-SS)

    14 days, 28 days

  • New York Heart Association (NYHA) functional classification

    14 days, 28 days

  • 6-minute walk test (6MWT)

    14 days, 28 days

Study Arms (2)

traditional Chinese medicine

EXPERIMENTAL

Subjects 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.

Drug: traditional Chinese medicine

placebo (gummeline)

PLACEBO COMPARATOR

Subjects 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.

Drug: Placebo (gummeline)

Interventions

traditional Chinese medicineDRUG

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.

Also known as: Qi deficiency：huangqi, dangshen, Blood stasis: danshen, chishao,taoren, honghua, Water retention: zexie, zhuling, cheqianzi, tinglizi, Yang deficiency: rougui, zhifuzi
traditional Chinese medicine
Placebo (gummeline)DRUG

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.

Also known as: Qi deficiency： gummeline, Blood stasis: gummeline, Water retention: gummeline, Yang deficiency: gummeline
placebo (gummeline)

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (2)

  • 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.

    PMID: 29213243DERIVED

  • 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.

    PMID: 26089951DERIVED

MeSH Terms

Interventions

Medicine, Chinese TraditionalHonghua extract, Carthamus tinctorius

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Study Officials

  • Wei Wang, Doctor

    Beijing University of Chinese Medicine

    STUDY CHAIR

  • Peng Zhang, Doctor

    Wuhan Hospital of Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Huihui Zhao, Doctor

    Beijing University of Chinese Medicine

    STUDY DIRECTOR

  • Liangtao Luo, Master

    Beijing University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-President

Study Record Dates

First Submitted

August 13, 2013

First Posted

September 11, 2013

Study Start

May 1, 2010

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

CN(1)