[Translation] A randomized double-blind multicenter clinical trial to evaluate the safety and efficacy of Fulubaoxinping oral liquid in the treatment of ventricular premature beats (Qi and Yin deficiency, phlegm and blood stasis syndrome) in coronary heart disease

对复律保心平口服液治疗冠心病室性早搏(气阴两虚、痰瘀互阻证) 24小时动态心电图优效性和安全性进行最终评价

[Translation]

Final evaluation of the efficacy and safety of Fulubaoxinping oral liquid in the treatment of ventricular premature beats in coronary heart disease (Qi and Yin deficiency, phlegm and blood stasis syndrome) on 24-hour dynamic electrocardiogram

Start Date03 Oct 2009

Sponsor / Collaborator

Tonghua Wantong Pharmaceutical Co. Ltd.

100 Clinical Results associated with Fulu baoxinping Oral Liquid

100 Translational Medicine associated with Fulu baoxinping Oral Liquid

100 Patents (Medical) associated with Fulu baoxinping Oral Liquid

Literatures (Medical) associated with Fulu baoxinping Oral Liquid

01 Jun 2008·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effect of fulu baoxinping oral liquid in treatment of coronary heart disease patients with premature ventricular beat].

Article

Author: Zhou, Ming-Xue ; Huang, Yong-Sheng ; Zhang, Qiong

OBJECTIVETo evaluate the efficacy and safety of Fulu Baoxinping (FLBXP) oral liquid in the treatment of coronary heart disease patients with premature ventricular beat (PVB), differentiated as qi-yin deficiency with phlegm-stasis syndrome type.METHODSAdopting randomized, double-blinded, double-simulated, positive drug parallel controlled and multi-centered clinical research method, 240 patients enrolled were randomly assigned equally to the treatment group treated with FLBXP 10 mL (containing 13.33 g of crude drug) thrice a day and the control group treated with Wenxin Granule 9 g thrice a day. Meanwhile, simulator of the test or positive control drug was given to them all correspondingly. The therapeutic course for them all was 28 days. Efficacy on PVB and TCM syndrome was observed.RESULTSThe markedly effective rate and total effective rate on PVB were 55.0% and 78.4% in the treatment group, and 37.2% and 53.1% in the control group, significant difference between groups was shown in comparison of both indexes (P < 0.05). Dynamic ECG showed the total number of PVB decreased for 3460.59 +/- 6516.56 beats/24 h in the treatment group, and for 2148.36 +/- 5129.47 beats/24 h in the control group, difference between them showed no statistical significance (P > 0.05). The TCM syndrome score in both groups was markedly decreased after treatment when compared with before treatment (P < 0.01); the differences of the treated and the control groups were -9.34 +/- 4.21 and -8.08 +/- 4.33 respectively, showing sigificant difference (P < 0.05).CONCLUSIONFLBXP oral liquid has certain effect on PVB in CHD patients of qi-yin deficiency with phlegm-stasis syndrome type, no obvious adverse reaction was found in the clinical trial.

01 Oct 2006·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effect of fulu baoxin oral liquid on lipid peroxidation, plasma nitric oxide and vascular endothelial growth factor in acute myocardial infarction rats].

Article

Author: Huang, Jing ; Huang, Yong-sheng

OBJECTIVETo study the effect and mechanism of Fulu Baoxin Oral Liquid (FBOL) on lipid peroxidation (LPO), plasma nitric oxide (NO) and vascular endothelial growth factor (VEGF) in myocadial tissue of rats with acute myocardial infarction (AMI).METHODSThe contents of superoxide dismutase (SOD), malondialdehyde (MDA) and VEGF in myocardial tissue and the plasm NO level were determined by immunohistochemical method.RESULTSCompared with those in AMI model rats, contents of SOD, plasma NO and myocardial VEGF were higher and MDA was lower obviously in the FBOL high dosage and coronary favorable medicine treated rats (P < 0.05 or P < 0.01).CONCLUSIONFBOL could increase SOD activity and lower MDA content in myocardial tissue, and up-regulate plasma NO and myocardial VEGF, which may be related to its curative effect on AMI.

100 Deals associated with Fulu baoxinping Oral Liquid

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Indication	Highest Phase	Country/Location	Organization	Date
Ventricular Premature Complexes	Phase 3	CN	Tonghua Wantong Pharmaceutical Co. Ltd.	03 Oct 2009

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