Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 3 of 5 for:    ACONITUM NAPELLUS ROOT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03027375
Recruitment Status : Unknown
Verified October 2017 by Wei Wang, Beijing University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : January 23, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborators:
China-Japan Friendship Hospital
Zhengzhou Hospital of Traditional Chinese Medicine
Beijing Anzhen Hospital
Information provided by (Responsible Party):
Wei Wang, Beijing University of Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Heart Failure Cardiovascular Diseases Drug: Qishen Granules Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure: Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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).
Drug: 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).
Other Name: 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).
Drug: 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.




Primary Outcome Measures :
  1. the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide [ Time Frame: 12weeks ]

Secondary Outcome Measures :
  1. composite cardiac events [ Time Frame: 4weeks,8weeks,12weeks ]
  2. New York Heart Association (NYHA) functional classification [ Time Frame: 4weeks,8weeks,12weeks ]
  3. 6-minute walking distance [ Time Frame: 4weeks,8weeks,12weeks ]
  4. Left ventricular ejection fraction [ Time Frame: 12weeks ]
  5. Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine [ Time Frame: 4weeks,8weeks,12weeks ]
  6. TCM syndrome integral scale [ Time Frame: 4weeks,8weeks,12weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027375


Contacts
Layout table for location contacts
Contact: Jinping Wang, Master 13810689802 wjpbucm@163.com

Locations
Layout table for location information
China, Beijing
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Jinping Wang, doctor         
Sponsors and Collaborators
Beijing University of Chinese Medicine
China-Japan Friendship Hospital
Zhengzhou Hospital of Traditional Chinese Medicine
Beijing Anzhen Hospital
Investigators
Layout table for investigator information
Study Chair: Wei Wang, Doctor Beijing University of Chinese Medicine
Study Director: Huihui Zhao, Doctor Beijing University of Chinese Medicine
Principal Investigator: Jinping Wang, Master Beijing University of Chinese Medicine

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wei Wang, Vice-President, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03027375    
Other Study ID Numbers: 2016-ZXFZJJ-003
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei Wang, Beijing University of Chinese Medicine:
chronic heart failure
traditional Chinese medicine
Qishen granules
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Cardiovascular Diseases
Heart Diseases