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

NCT03027375 | Unknown Phase 2

• 1 other identifier: 2016-ZXFZJJ-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Cardiovascular Diseases

Keywords

chronic heart failure; traditional Chinese medicine; Qishen granules

Outcome Measures

Primary Outcomes (1)

• the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide

  12weeks

Secondary Outcomes (6)

• composite cardiac events

  4weeks,8weeks,12weeks

• New York Heart Association (NYHA) functional classification

  4weeks,8weeks,12weeks

• 6-minute walking distance

  4weeks,8weeks,12weeks

• Left ventricular ejection fraction

  12weeks

• Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine

  4weeks,8weeks,12weeks

Study Arms (2)

Qishen granules

EXPERIMENTAL

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).

Drug: Qishen Granules

placebo granules

PLACEBO COMPARATOR

The placebo group will receive placebo granules (13.6 g/pouch, twice per day-30 minutes after breakfast and dinner-for 12 weeks).

Drug: Placebo

Interventions

Qishen Granules DRUG

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).

Also known as: Yixin Jiedu formula

Qishen granules

Placebo DRUG

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.

placebo granules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead
• China-Japan Friendship Hospital: collaborator
• Zhengzhou Hospital of Traditional Chinese Medicine: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 23747768 BACKGROUND

• 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.

  PMID: 25951678 BACKGROUND

• 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.

  PMID: 11273440 BACKGROUND

• 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.

  PMID: 26727047 RESULT

• 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.

  PMID: 36618925 DERIVED

• 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.

  PMID: 29017565 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Interventions

qishen granule

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Wei Wang, Doctor

  Beijing University of Chinese Medicine

  STUDY CHAIR

• Huihui Zhao, Doctor

  Beijing University of Chinese Medicine

  STUDY DIRECTOR

• Jinping Wang, Master

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinping Wang, Master

CONTACT

13810689802; wjpbucm@163.com

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: January 16, 2017
• First Posted: January 23, 2017
• Study Start: March 31, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)