加参片(Jiashen Tablets) - 在研适应症：慢性心力衰竭，冠心病_专利_临床

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

心血管疾病

在研适应症

慢性心力衰竭冠心病

非在研适应症-

原研机构-

在研机构

天士力医药集团股份有限公司

天津中医药大学

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

6

项与加参片相关的临床试验

CTR20170730 / Suspended临床1期

加参片I期健康人体耐受性试验

以健康成年受试者为研究对象，进行加参片人体耐受性试验，从安全的初始剂量开始，观察人体对加参片的耐受性及其产生的不良反应，确定安全耐受的人用剂量，了解在此剂量下的不良反应，为加参片后期临床研究提供安全的剂量范围和设计依据。

开始日期-

申办/合作机构

天津中医药大学

[+1]

CTR20192699 / Completed临床1期

加参片I期临床健康人耐受性+药代动力学试验

1）以健康成年受试者为研究对象，进行加参片人体耐受性试验，确定人用耐受剂量范围及可能的不良反应。（2）在累积给药耐受性试验组加载开展药代动力学试验，检测加参片活性成分血药浓度，并估算药动学参数，评价其药动学特征。（3）为加参片后期临床试验方案制定提供试验依据。

开始日期2020-07-02

申办/合作机构

天津中医药大学

[+1]

NCT04164290 / Completed临床1期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Jiashen Tablets in Healthy Subjects

Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an effect on improvement of the heart failure. This study will assess the safety, tolerability and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and multiple ascending dose of Jiashen Tablets.

开始日期2020-06-29

申办/合作机构

天士力医药集团股份有限公司

100 项与加参片相关的临床结果

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100 项与加参片相关的转化医学

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100 项与加参片相关的专利（医药）

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2

项与加参片相关的文献（医药）

2023-02-01·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Rapid health technology assessment of four oral Chinese patent medicines in treatment of functional gastrointestinal disorders].

Article

作者: Yu, Qi ; Li, Jing-Hua ; Liao, Xing ; Li, Guo-Xiang ; Shi, Wen-Yan ; Zu, Ya-Qi ; Tang, Xu-Dong

To provide proof of the evidence-based medicine and decision-making information for the clinical decision of functional gastrointestinal disorders(FGIDs), this study evaluated and compared the efficacy, safety, and economy of four oral Chinese patent medicines(CPMs) in the treatment of FGIDs using the method of rapid health technology assessment. The literature was systematically retrieved from CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, Cochrane Library and ClinicalTrials.gov from the establishment of the databases to May 1, 2022. Two evaluators screened out the literature, extracted data, evaluated the quality of the literature, and descriptively analyzed the results according to the prepared standard. Eventually, 16 studies were included, all of which was rando-mized controlled trial(RCT). The results showed that Renshen Jianpi Tablets, Renshen Jianpi Pills, Shenling Baizhu Granules, and Buzhong Yiqi Granules all had certain effects on the treatment of FGIDs. Renshen Jianpi Tablets treated FGIDs and persistent diarrhea. Shenling Baizhu Granules treated diarrhea with irritable bowel syndrome and FGIDs. Buzhong Yiqi Granules treated diarrhea with irritable bowel syndrome, FGIDs, and chronic diarrhea in children. Renshen Jianpi Pills treated chronic diarrhea. The four oral CPMs all have certain effects on the treatment of FGIDs and have specific advantages for specific patients. Compared with other CPMs, Renshen Jianpi Tablets have higher clinical universality. However, there are problems such as insufficient clinical research evidence, generally low quality of evidence, lack of comparative analysis among medicines, and lack of academic evaluation. More high-quality clinical research and the economic research should be carried out in the future, so as to provide more evidence for the evaluation of the four CPMs.

Frontiers in Cardiovascular Medicine

Plasma metabolomic analysis reveals the therapeutic effects of Jiashen tablets on heart failure

Article

作者: He, Yi ; Miao, Xinglong ; He, Xin ; Luo, Jiayi ; Ma, Jiang ; Chen, Jiaping ; Su, Yangyan

BackgroundHeart failure is a chronic progressive condition that significantly affects the quality of life of patients with high hospitalization and mortality rates. Jiashen tablets (JST), a Chinese herbal formula, have been reported to be an effective treatment against heart failure, however the underlying mechanisms remain obscure. This study was designed to determine the effect of JST on the treatment of heart failure and delineate the underlying mechanisms by an untargeted metabolomics approach.Materials and methodsThe chronic heart failure model was established by the permanent ligation of the left anterior descending coronary artery in rats. The cardiac functions of rats, including left ventricular ejection fraction (LVEF) and fractional shortening (LVFS), left ventricular internal diameter end diastole (LVIDd) and end systole (LVIDs), and interventricular septum thickness in diastole (IVSd) and in systole (IVSs), were measured by echocardiography. Biochemical analysis and histopathological examination were also performed to evaluate therapeutic effects of JST for treating heart failure. UHPLC-QTOF-MS/MS coupled with multivariate statistical analyses were applied for plasma metabolic profiling to identify biomarkers and potential mechanisms of JST in the treatment of heart failure.ResultsJiashen tablets could improve the cardiac function of heart failure rats and thus ameliorate heart failure via enhancing rat LVEF and LVFS and decreasing LVIDd, LVIDs, IVSd, and IVSs. Results of biochemical analysis and histopathological examination revealed that JST could reduce the serum lactate dehydrogenase (LDH) activity and the level of NT-pro BNP, markers of heart failure and myocardial damage, and inhibit myocardial fibrosis. Furthermore, in metabolomics analysis, a total of 210 metabolites with significant differences were identified between heart failure rats and normal rats, among which 29 metabolites were significantly restored after JST treatment. These metabolites were primarily involved in tryptophan metabolism, branched-chain amino acid metabolism, fatty acids β-oxidation, and glycerophospholipid metabolism.ConclusionThe present study illustrated the therapeutic effect of JST for the treatment of heart failure and delineated the underlying mechanisms mainly relating to the regulation of amino acid metabolism and lipid metabolism in heart failure rats.

100 项与加参片相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性心力衰竭	临床2期	中国	天士力医药集团股份有限公司	2024-10-16
慢性心力衰竭	临床2期	中国	天津中医药大学	2024-10-16
冠心病	临床2期	中国	天津中医药大学	2024-10-16
冠心病	临床2期	中国	天士力医药集团股份有限公司	2024-10-16