Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure

October 6, 2017 updated by: Wei Wang, Beijing University of Chinese Medicine

Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial

This trial will assess the efficacy and safety of QSG in CHF.

Study Overview

Status

Unknown

Detailed Description

Background: Chronic heart failure(CHF), the final stage of various cardiovascular diseases, is a major public health problem associated with significant hospitalization rates, mortality, and huge health care costs, despite advances in the treatment and management of heart failure and heart failure related risk factors. Qishen granules(QSG), a Chinese herbal formula, is widely used by traditional chinese medicine(TCM) practitioners to treat CHF. Several animal experimental studies have showed that QSG can significantly relieve the heart failure symptoms of CHF rat models. However, there is yet no standard clinical trial to assess that. Thus, the investigators are conducting this study to evaluate the efficacy and safety of QSG in a large, varied population.

Methods/Design: This study is designed as a randomized, multi-center, placebo-controlled, double-blind , parallel-group clinical trial. An established total of 200 patients with CHF will be recruited and randomly allocated to either the QSG treatment group or the placebo group (a 1:1 ratio). The patients will receive QSG or placebo granules twice daily for 12 weeks. The primary endpoint is the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP) level during 12 weeks of treatment. The secondary endpoints consist of composite cardiac events (CCEs), New York Heart Association (NYHA) functional classification, 6-minute walking distance (6MWD), Left ventricular ejection fraction, patient quality of life and TCM syndrome integral scale.

Discussion: This trial will assess the efficacy and safety of QSG in CHF.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jinping Wang, Master
  • Phone Number: 13810689802
  • Email: wjpbucm@163.com

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Jinping Wang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age between 18 and 75 years;
  2. clinical findings of CHF for at least 3 months prior to screening;
  3. CHF caused by coronary heart disease and hypertension, which is diagnosed according to the Chinese guidelines published in 2014 for the diagnosis and management of CHF;
  4. clinically stable condition with an NYHA functional class of II to III and an optimal medical treatment with a fixed dosage for at least 2 weeks;
  5. a documented left ventricular ejection fraction (LVEF) ≤40% and a serum NT-proBNP level ≥450 pg/ml;
  6. CHF of Qi deficiency and blood stasis syndrome;
  7. provision of written informed consent.

Exclusion Criteria:

  1. CHF complicated with severe valvular disease, congenital heart disease, pericardial disease, cardiomyopathy, unstable angina, acute myocardial infarction(in recent 4 weeks), cardiogenic shock, acute myocarditis, infective endocarditis, uncontrolled severe cardiac arrhythmia with hemodynamic changes;
  2. pulmonary heart disease, pulmonary hypertension caused by acute or chronic pulmonary embolism or cerebral apoplexy in recent 6 months;
  3. severe hepatic inadequacy with alanine aminotransferase or alkaline phosphatase levels >2 times the upper normal limit, renal inadequacy with a creatinine clearance rate>20% or a serum creatinine level>3mg/dl (>265μmol/L), severe electrolyte imbalance, severe hematologic disease, malignant tumor, diabetes mellitus with severe complications, or severe endocrine diseases such as hyperthyroidism and hypothyroidism;
  4. acute infection confirmed by any one of the following 3 tips: 1) fever; 2) a white blood cell count>10×109/L and a percentage of neutrophils>85%; 3) shadows on chest X-ray;
  5. uncontrolled blood pressure or fibrosis in other organs;
  6. CHF of yin deficiency according to TCM syndrome differentiation;
  7. pregnancy or breastfeeding;
  8. psychiatric or infectious disease;
  9. patients who have participated in other clinical trials in the past two months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Qishen granules
The QSG treatment group will receive Qishen granules (13.6 g/pouch, twice per day-30 minutes after breakfast and dinner-for 12 weeks; dosage based on the requirements of Pharmacopoeia of the People's Republic of China).
The QSG are manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China), a company that has obtained Chinese Good Manufacturing Practice for Pharmaceutical Products certification. All the ingredients have been approved by the Chinese Ministry of Food and Drug Safety. 13.6 grams (dry weight) of granules consist of six herbs: Astragalus membranaceus (Fisch.) Bge. var. Mongolicus (Bge.) Hsiao (6g), Salvia miltiorrhiza Bge. (1.5g), Lonicera japonica Thunb. (2g), Scrophularia ningpoensis Hemsl. (2g), Aconitum carmichaeli Debx. (0.9g), and Glycyrrhiza uralensis Fisch. (1.2g).
Other Names:
  • Yixin Jiedu formula
PLACEBO_COMPARATOR: placebo granules
The placebo group will receive placebo granules (13.6 g/pouch, twice per day-30 minutes after breakfast and dinner-for 12 weeks).
The placebo is manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China) as well, following the Specification for processing Chinese medicine in Beijing. The placebo granules are similar in appearance, taste, and scent to the Qishen granules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide
Time Frame: 12weeks
12weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
composite cardiac events
Time Frame: 4weeks,8weeks,12weeks
4weeks,8weeks,12weeks
New York Heart Association (NYHA) functional classification
Time Frame: 4weeks,8weeks,12weeks
4weeks,8weeks,12weeks
6-minute walking distance
Time Frame: 4weeks,8weeks,12weeks
4weeks,8weeks,12weeks
Left ventricular ejection fraction
Time Frame: 12weeks
12weeks
Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine
Time Frame: 4weeks,8weeks,12weeks
4weeks,8weeks,12weeks
TCM syndrome integral scale
Time Frame: 4weeks,8weeks,12weeks
4weeks,8weeks,12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jinping Wang, Master, Beijing University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-ZXFZJJ-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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