[Translation] A randomized, double-blind, single-dummy, placebo-controlled, multicenter clinical trial on the efficacy and safety of Tongshuan Jiuxin Tablets in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome)

以安慰剂为对照，评价通栓救心片治疗慢性稳定性心绞痛（气滞血瘀证）的有效性及安全性。

[Translation]

To evaluate the efficacy and safety of Tongshuan Jiuxin Tablets in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome) using placebo as control.

Start Date23 Dec 2014

Sponsor / Collaborator

Ginwa Enterprise (Group) Inc.

[+1]

CTR20131333 / CompletedPhase 2

通栓救心片治疗冠心病心绞痛有效性及安全性的随机、双盲双模拟平行对照、多中心II期临床试验

[Translation] A randomized, double-blind, double-dummy, parallel-controlled, multicenter phase II clinical trial on the efficacy and safety of Tongshuan Jiuxin Tablets in the treatment of angina pectoris due to coronary heart disease

对通栓救心片治疗冠心病心绞痛（气滞血瘀证）的临床用药剂量进行初步探索，为Ⅲ期临床试验用药提供依据,对临床有效性进行初步探索及评价，对临床安全性进行评价。

[Translation]

A preliminary exploration was conducted on the clinical dosage of Tongshuan Jiuxin Tablets in the treatment of angina pectoris (Qi stagnation and blood stasis syndrome) of coronary heart disease, to provide a basis for the use of drugs in Phase III clinical trials, to conduct a preliminary exploration and evaluation of the clinical effectiveness, and to evaluate the clinical safety.

Start Date10 Feb 2011

Sponsor / Collaborator

Ginwa Enterprise (Group) Inc.

[+1]

CTR20131307 / CompletedPhase 1

通栓救心片治疗冠心病心绞痛进行Ⅰ期临床人体耐受性试验研究

[Translation] Phase I clinical human tolerance study on Tongshuan Jiuxin Tablets in the treatment of angina pectoris due to coronary heart disease

选择健康志愿者，从安全的初始剂量开始，考察正常人体对通栓救心片的耐受性和安全性，为制定本品的Ⅱ期临床试验给药方案提供依据。

[Translation]

Healthy volunteers were selected to start with a safe initial dose to examine the tolerance and safety of Tongshuan Jiuxin Tablets in the normal human body, so as to provide a basis for formulating the dosing regimen for the Phase II clinical trial of this product.

Start Date09 Mar 2009

Sponsor / Collaborator

Ginwa Enterprise (Group) Inc.

[+1]

100 Clinical Results associated with Ginwa Enterprise (Group) Inc.

0 Patents (Medical) associated with Ginwa Enterprise (Group) Inc.

Literatures (Medical) associated with Ginwa Enterprise (Group) Inc.

Chinese Medicine

Jin-Tian-Ge ameliorates ovariectomy-induced bone loss in rats and modulates osteoblastogenesis and osteoclastogenesis in vitro

Article

Author: Wang, Yang ; Zhang, Qi ; Qin, Luping ; Wang, Na ; Wu, Qudi ; Shen, Yi ; Zhang, Qiaoyan ; Zhang, Quanlong ; Zhao, Qiming ; He, Yuqiong ; Liu, Yuling ; Wang, Xiaoyan

AbstractBackgroundTiger bone, which had been one of the most famous traditional Chinese medicine for 2000 years, was originate from the skeleton of Panthera tigris L., and had the actions of anti-inflammatory, analgesic, immune-regulatory and promoting healing of bone fracture, and was used for the treatment of osteoporosis and rheumatoid arthritis. Jin-Tian-Ge (JTG), the artificial tiger bone powder, were prepared from skeletons of several farmed animals to substitute the natural tiger bone, and has been used for the treatment of osteoporosis in clinical practice. However, the characteristic and mechanism of action of JTG for the therapy of osteoporosis need to be further evidenced by using modern pharmacological methods. The aim of this work is to investigate the bone-protective effects of JTG, and explore the possible underlying mechanism.MethodsOvariectomy (OVX) rats were orally administrated JTG or estradiol valerate (EV) for 12 weeks. We investigated the pharmacodynamic effects of JTG on anti-bone loss in OVX rats, and also investigated the role of JTG in promoting osteogenesis and inhibiting osteoclast differentiation.ResultsJTG increased the bone mineral density (BMD), improved the bone microarchitecture and biomechanical properties in ovariectomized rast, whereas reversed the bone high turnover in OVX rats as evidenced by serum biochemical markers in OVX rats. JTG increased osteogenic differentiation of BMSCs in vitro, and up-regulated the expression of the key proteins of BMP and Wnt/β-catenin pathways. JTG also inhibited the osteoclastogenesis of BMM as evidenced by the alteration of the TRAP activity, F-actin construction and the expression of nuclear factor of activated T-cells cytoplasmic 1 (NFATc1), c-Fos, Cathepsin K (Ctsk) and matrix metallopeptidase 9 (MMP9) of OCs induced with RANKL and LPS, reduced the expression and phosphorylation of NF-κB in OCs.ConclusionsJTG prevented bone loss in OVX rats and increased osteogenic differentiation of BMSCs through regulation of the BMP and Wnt/β-catenin pathway, inhibited osteoclastogenesis by suppressing the NF-κB pathway, suggesting that JTG had the potentials for prevention and treatment of osteoporosis by modulating formation and differentiation of osteoblast and osteoclast.

Journal of Inflammation ResearchQ3 · MEDICINE

Jintiange Capsule Alleviates Rheumatoid Arthritis and Reverses Changes of Serum Metabolic Profile in Collagen-Induced Arthritic Rats

Q3 · MEDICINE

ArticleOA

Author: Lu, Xinyu ; Zhang, Qiaoyan ; Zhu, Lulin ; Liu, Yuling ; Zhuang, Xinying ; Wang, Na ; Zhang, Qi ; Qin, Luping ; Wang, Xiaoyan ; Shen, Yi

PURPOSEJintiange capsule (JTG), an approved drug developed as a substitute for tiger bone (TB), has been clinically applied for osteoporosis therapy since 2003. The drug is composed of bionic TB powder, in which peptides and proteins are primarily enriched from other bone extracts. However, as a precious material of traditional Chinese medicine (TCM), TB has been mainly understood and used in TCM to relieve osteoporosis, rheumatoid arthritis and bone injury. Inspired by those, the purpose of this study was to investigate whether JTG also had an effect on relieving rheumatoid arthritis in collagen-induced arthritic (CIA) rats and explore potential mechanism from the perspective of serum metabolic profile changes.METHODSJTG was analyzed using Nano LC-MS/MS and orally administered in CIA rats for 6 weeks. After administration, intervention effects of JTG on synovial inflammation, bone micro-architecture and bone metabolism were studied, and the impact of JTG on serum metabolic profiles in CIA rats was investigated by metabolomics.RESULTSNine bioactive peptides were identified in JTG. In animal treatments, JTG alleviated paw swelling (P < 0.01), arthritic severity (P < 0.01) and synovial tissue proliferation, as well as inflammatory cell infiltration of ankle joint, decreased bone loss, improved microstructure of bone in CIA rats by regulating bone absorption and formation, specifically increasing bone mineral density (BMD) (P < 0.05), bone volume fraction (BVF) (P < 0.05), trabecular number (Tb.N) (P < 0.05) and decreasing trabecular separation (Tb.Sp) (P < 0.05). Besides, serum IL-6 was down-regulated remarkably in CIA rats (P < 0.05). Furthermore, metabolomics analysis revealed that 32 metabolites were regulated significantly (P < 0.05) by comparison between CIA model and JTG in 360 mg/kg dose. The pathway analysis implied that JTG was involved in regulation of biosynthesis of phenylalanine.CONCLUSIONJTG alleviates rheumatoid arthritis and reverses changes in serum metabolic profile in CIA rats.

100 Deals associated with Ginwa Enterprise (Group) Inc.

100 Translational Medicine associated with Ginwa Enterprise (Group) Inc.

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Drug(Targets)	Indications	Global Highest Phase

Tongshuan Jiuxin Tablets	Coronary Artery Disease More	Phase 3

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