- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03027375
Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure
Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 75 years;
- clinical findings of CHF for at least 3 months prior to screening;
- 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;
- 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;
- a documented left ventricular ejection fraction (LVEF) ≤40% and a serum NT-proBNP level ≥450 pg/ml;
- CHF of Qi deficiency and blood stasis syndrome;
- provision of written informed consent.
Exclusion Criteria:
- 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;
- pulmonary heart disease, pulmonary hypertension caused by acute or chronic pulmonary embolism or cerebral apoplexy in recent 6 months;
- 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;
- 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;
- uncontrolled blood pressure or fibrosis in other organs;
- CHF of yin deficiency according to TCM syndrome differentiation;
- pregnancy or breastfeeding;
- psychiatric or infectious disease;
- patients who have participated in other clinical trials in the past two months.
Study Plan
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:
|
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
Collaborators
Investigators
- Principal Investigator: Jinping Wang, Master, Beijing University of Chinese Medicine
Publications and helpful links
General Publications
- Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.
- General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.
- Switula D. Principles of good clinical practice (GCP) in clinical research. Sci Eng Ethics. 2000 Jan;6(1):71-7. doi: 10.1007/s11948-000-0025-z.
- van Riet EE, Hoes AW, Wagenaar KP, Limburg A, Landman MA, Rutten FH. Epidemiology of heart failure: the prevalence of heart failure and ventricular dysfunction in older adults over time. A systematic review. Eur J Heart Fail. 2016 Mar;18(3):242-52. doi: 10.1002/ejhf.483. Epub 2016 Jan 4.
- Wang J, Shi J, Wei J, Wang J, Gao K, Li X, Chen J, Li S, Zhao H, Wang W. Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial. Trials. 2017 Oct 10;18(1):468. doi: 10.1186/s13063-017-2193-z.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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