Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure
NCT ID: NCT03027375
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2017-03-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
Qishen Granules
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).
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).
Placebo
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.
Interventions
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Qishen Granules
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).
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Zhengzhou Hospital of Traditional Chinese Medicine
OTHER
Beijing Anzhen Hospital
OTHER
Beijing University of Chinese Medicine
OTHER
Responsible Party
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Wei Wang
Vice-President
Principal Investigators
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Wei Wang, Doctor
Role: STUDY_CHAIR
Beijing University of Chinese Medicine
Huihui Zhao, Doctor
Role: STUDY_DIRECTOR
Beijing University of Chinese Medicine
Jinping Wang, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing University of Chinese Medicine
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jinping Wang, doctor
Role: primary
References
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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.
Du K, Liu J, Tan N, Huang X, Wang J, Zhao H, Wang W. The effects of qishen granules for patients with chronic heart failure: A multicenter randomized double-blind placebo-controlled trial. Front Pharmacol. 2022 Dec 23;13:1017734. doi: 10.3389/fphar.2022.1017734. eCollection 2022.
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.
Other Identifiers
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2016-ZXFZJJ-003
Identifier Type: -
Identifier Source: org_study_id