黄甲软肝颗粒(Huangjia Ruangan Granules) - 在研适应症：肝纤维化，慢性乙型肝炎，肝硬化_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

感染消化系统疾病其他疾病

在研适应症

肝纤维化慢性乙型肝炎肝硬化

非在研适应症-

原研机构-

在研机构

牡丹江友搏药业有限责任公司

北京盈科瑞创新医药股份有限公司

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-

登录后查看时间轴

关联

3

项与黄甲软肝颗粒相关的临床试验

CTR20132142 / Not yet recruiting临床2期

评价黄甲软肝颗粒治疗慢性乙型肝炎肝纤维化（脾虚肝郁，气血瘀阻证）随机、双盲、多中心Ⅱa期临床试验

(1)与安慰剂做对照，评价黄甲软肝颗粒治疗慢性乙型肝炎肝纤维化的临床疗效。 (2)通过实验室检查、临床症状、不良事件等，评价本品临床使用的安全性。

开始日期-

申办/合作机构

北京盈科瑞创新医药股份有限公司

[+1]

CTR20181151 / Completed临床2期

评价黄甲软肝颗粒治疗慢性乙型肝炎肝纤维化(肝郁脾虚兼瘀血阻络证)有效性和安全性的多中心Ⅱ期临床试验

初步评价黄甲软肝颗粒治疗慢性乙型病毒性肝炎肝纤维化 (肝郁脾虚兼瘀血阻络证)的有效性、安全性。对黄甲软肝颗粒治疗慢性乙型病毒性肝炎肝纤维化 (肝郁脾虚兼瘀血阻络证)进行剂量探索。对肝纤维化的有创和无创诊断方法进行比较研究。

开始日期2018-10-21

申办/合作机构

北京盈科瑞创新医药股份有限公司

[+1]

ChiCTR2400086796 / Completed临床2期IIT

Huangjia Ruangan Granules Phase II Clinical Trial

开始日期2018-10-21

申办/合作机构-

100 项与黄甲软肝颗粒相关的临床结果

登录后查看更多信息

100 项与黄甲软肝颗粒相关的转化医学

登录后查看更多信息

100 项与黄甲软肝颗粒相关的专利（医药）

登录后查看更多信息

8

项与黄甲软肝颗粒相关的文献（医药）

2023-12-31·Cancer Biology & Therapy

Ruangan Lidan decoction inhibits the growth and metastasis of liver cancer by downregulating miR-9-5p and upregulating PDK4

Article

作者: Si, Tao ; Huang, Liyin ; Zhang, Mingmin ; Huang, Ping ; Liang, Ting ; Zhou, Xiaoling ; Zhang, Hongyu

A growing number of studies have suggested that traditional Chinese medicine (TCM) plays an essential role in the development and occurrence of liver cancer. However, the function of Ruangan Lidan decoction (RLD) in liver cancer are not yet adequately identified and manifested, which attracted our attention. The key genes related to liver cancer and RLD and the upstream miRNAs of PDK4 were obtained based on bioinformatics analysis, followed by verification of the targeting relationship between miR-9-5p and PDK4. Next, Huh7 cells were treated with RLD to detect cell proliferation, colony formation, migration, invasion, and apoptosis by multiple assays with gain- and loss-of-function experiments. Moreover, subcutaneous transplanted tumor model and lung metastasis model of liver cancer in nude mice were established to further verify the functional role of RLD in liver cancer growth and metastasis via miR-9-5p/PDK4 axis. Bioinformatics analysis found that PDK4 and miR-9-5p were related to liver cancer, and PDK4 may be a downstream regulator of RLD. miR-9-5p could target and inhibit PDK4. In vitro cell experiments demonstrated that RLD suppressed liver cancer cell proliferation, invasion and migration, and promoted apoptosis by inhibiting miR-9-5p expression and promoting PDK4 expression. In vivo animal experiments further confirmed that RLD inhibited liver cancer growth and metastasis via upregulation of miR-9-5p-dependent PDK4. RLD downregulated miR-9-5p and upregulated PDK4 to inhibit the proliferation, migration, invasion, and induce apoptosis, thereby suppressing the growth and metastasis of liver cancer, highlighting a potential novel target for treatment of liver cancer.

2023-04-01·Pharmacological Research

Chinese herbal formula ruangan granule enhances the efficacy of entecavir to reverse advanced liver fibrosis/early cirrhosis in patients with chronic HBV infection: A multicenter, randomized clinical trial

Article

作者: Peng, Deti ; Feng, Lian ; Jiang, Kaiping ; Deng, Xin ; Han, Zhiyi ; Chen, Mingtai ; Zhou, Hua ; Zeng, Hua ; Zhong, Weichao ; Xu, Linyi ; Wang, Yanqing ; Huang, Jinzhen ; Tong, Guangdong ; Xing, Yufeng ; Zhou, Daqiao

BACKGROUNDNucleotide analogs treatment can reverse liver fibrosis in chronic hepatitis B (CHB). However, it has limited effect on fibrosis resolution in patients with CHB, particularly in preventing progression to hepatocellular carcinoma (HCC). Ruangan granule (RG), a Chinese herbal formula, has proven to produce a therapeutic effect against liver fibrosis in animal experiment. Thus, we aimed to evaluate the effect of our Chinese herbal formula (RG) combined with entecavir (ETV) to reverse advanced liver fibrosis/early cirrhosis from CHB.METHODSA total of 240 CHB patients with histologically confirmed advanced liver fibrosis/early cirrhosis from 12 centers were randomly and blindly allocated to consume either ETV (0.5 mg/day) plus RG (2 times/day) or control (ETV) for 48 weeks (wk) treatment. Changes in histopathology, serology and imageology were observed. Liver fibrosis reversion, defined as a reduction in the Knodell HAI score by ≥ 2 points and Ishak score by ≥ 1 grade, was assessed.RESULTSThe rate of fibrosis regression and inflammation remission after 48 wk of treatment in histopathology was significantly higher in the ETV + RG group (38.73% vs. 23.94%, P = 0.031). The ultrasonic semiquantitative scores decreased by ≥ 2 points and were 41 (28.87%) and 15 (21.13%) in the ETV+RG and ETV groups, respectively (P = 0.026). The ETV+RG group had a significantly lower Fibrosis-4 score (FIB-4) index (P = 0.028). There was a significant difference between the ETV+RG and ETV groups in the liver function normalization rate (P < 0.01). Moreover, ETV plus RG combination treatment further reduced the risk of HCC in median 55-month follow-up (P < 0.01).CONCLUSIONSThis study illustrates that the Chinese herbal formula RG with ETV can improve advanced liver fibrosis/early cirrhosis regression in patients with CHB, further reducing the risk of HCC.

2022-12-17·Computational and Mathematical Methods in Medicine

Systems Pharmacology-Based Strategy to Investigate the Mechanism of Ruangan Lidan Decoction for Treatment of Hepatocellular Carcinoma

Article

作者: Cai, Min ; Feng, Dongshan ; Zhou, Zheyi ; Wu, Qihui ; Zhang, Mingmin ; Chen, Cuilan ; Liang, Ting ; Si, Tao ; Tao, Jingrui

epatocellular carcinoma (HCC) is one of the leading contributors to cancer mortality worldwide. Currently, the prevention and treatment of HCC remains a major challenge. As a traditional Chinese medicine (TCM) formula, Ruangan Lidan decoction (RGLD) has been proved to own the effect of relieving HCC symptoms. However, due to its biological effects and complex compositions, its underlying mechanism of actions (MOAs) have not been fully clarified yet. In this study, we proposed a pharmacological framework to systematically explore the MOAs of RGLD against HCC. We firstly integrated the active ingredients and potential targets of RGLD. We next highlighted 25 key targets that played vital roles in both RGLD and HCC disease via a protein-protein interaction (PPI) network and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses. Furthermore, an ingredient-target network of RGLD consisting of 216 ingredients with 306 targets was constructed, and multilevel systems pharmacology analyses indicated that RGLD could act on multiple biological processes related to the pathogenesis of HCC, such as cellular response to hypoxia and cell proliferation. Additionally, integrated pathway analysis of RGLD uncovered that RGLD might treat HCC through regulating various pathways, including MAPK signaling pathway, PI3K/Akt signaling pathway, TNF signaling pathway, and ERBB signaling pathway. Survival analysis results showed that HCC patients with low expression of VEGFA, HIF1A, CASP8, and TOP2A were related with a higher survival rate than those with high expression, indicating the potential clinical significance for HCC. Finally, molecular docking results of core ingredients and targets further proved the feasibility of RGLD in the treatment of HCC. Overall, this study indicates that RGLD may treat HCC through multiple mechanisms, which also provides a potential paradigm to investigate the MOAs of TCM prescription.

100 项与黄甲软肝颗粒相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肝纤维化	临床2期	中国	牡丹江友搏药业有限责任公司	2014-04-29
肝纤维化	临床2期	中国	北京盈科瑞创新医药股份有限公司	2014-04-29
慢性乙型肝炎	临床2期	中国	牡丹江友搏药业有限责任公司	2014-04-29
慢性乙型肝炎	临床2期	中国	北京盈科瑞创新医药股份有限公司	2014-04-29
肝硬化	临床2期	中国	北京盈科瑞创新医药股份有限公司	2014-04-29
肝硬化	临床2期	中国	牡丹江友搏药业有限责任公司	2014-04-29