Evaluating the Safety and Efficacy of Qishen Granules Among Patients With Chronic Heart Failure
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|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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiovascular Diseases||Drug: Qishen Granules Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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).
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.
- the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide [ Time Frame: 12weeks ]
- composite cardiac events [ Time Frame: 4weeks,8weeks,12weeks ]
- New York Heart Association (NYHA) functional classification [ Time Frame: 4weeks,8weeks,12weeks ]
- 6-minute walking distance [ Time Frame: 4weeks,8weeks,12weeks ]
- Left ventricular ejection fraction [ Time Frame: 12weeks ]
- Chronic Heart Failure Quality of Life Scale of Integrated Chinese and Western Medicine [ Time Frame: 4weeks,8weeks,12weeks ]
- TCM syndrome integral scale [ Time Frame: 4weeks,8weeks,12weeks ]
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
|Contact: Jinping Wang, Masterfirstname.lastname@example.org|
|China-Japan Friendship Hospital||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Jinping Wang, doctor|
|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|