[Translation] A single-arm, multicenter phase IV clinical study on the safety and efficacy of Huazhi Rougan Granule in the treatment of non-alcoholic simple fatty liver disease (damp-heat obstruction syndrome)

评价化滞柔肝颗粒治疗非酒精性单纯性脂肪肝（湿热中阻证）安全性和有效性。

[Translation]

To evaluate the safety and efficacy of Huazhi Rougan Granule in the treatment of non-alcoholic simple fatty liver disease (damp-heat obstruction syndrome).

Start Date13 May 2020

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

NCT06202456

/ CompletedPhase 4

A Single-arm, Multicenter Phase IV Study to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver (Damp-heat Obstruction Syndrome: Shi-Re-Zhong-Zu Zheng)

An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period

Start Date13 May 2020

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

CTR20160739

/ CompletedPhase 4

化滞柔肝颗粒治疗非酒精性单纯性脂肪肝有效性和安全性的随机、双盲、多中心IV期临床试验

[Translation] A randomized, double-blind, multicenter phase IV clinical trial on the efficacy and safety of Huazhi Rougan Granule in the treatment of nonalcoholic simple fatty liver disease

评价化滞柔肝颗粒治疗非酒精性单纯性脂肪肝（湿热中阻证）的有效性和安全性以及对代谢综合征相关表现的影响

[Translation]

To evaluate the efficacy and safety of Huazhi Rougan Granule in the treatment of non-alcoholic simple fatty liver disease (damp-heat obstruction syndrome) and its effect on metabolic syndrome-related manifestations

Start Date22 May 2017

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

100 Clinical Results associated with Huazhi Rougan Granules

100 Translational Medicine associated with Huazhi Rougan Granules

100 Patents (Medical) associated with Huazhi Rougan Granules

Literatures (Medical) associated with Huazhi Rougan Granules

01 Dec 2024·Phytomedicine

Comparative effectiveness of five Chinese patent medicines for non-alcoholic fatty liver disease: A systematic review and Bayesian network meta-analysis

Review

Author: Wu, Jiarui ; Zhang, Xiaomeng ; Shi, Rui ; Guo, Siyu ; Huang, Jiaqi ; Zhai, Yiyan ; Li, Jiaqi ; Chai, Keyan ; Zhou, Jiying ; Yang, Siyun ; Wang, Haojia ; Qiao, Chuanqi ; Sheng, Xiaoguang

BACKGROUNDNon-alcoholic fatty liver disease (NAFLD) is a metabolically stressed liver injury closely related to insulin resistance and genetic susceptibility and has become the leading chronic liver disease in China.PURPOSETo analyze the effectiveness of five Chinese patent medicines used alone or in combination with western medications (WM) for NAFLD using Bayesian network meta-analysis.METHODSSearches were conducted in Embase, Cochrane Library, PubMed, CNKI, Wanfang Database, VIP, and SinoMed for randomized controlled trials (RCTs) on Danning tablets, Huazhi Rougan granules, Dangfei Liganning capsules, Kezhi capsules, and Qianggan capsules, either alone or in combination with WM for NAFLD, up to January 10, 2024. This study was screened based on pre-designed inclusion and exclusion criteria, and the risk of bias was evaluated using the Cochrane ROB2 tool. The primary outcome was clinical efficacy rate, while secondary outcomes included levels of Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Triglycerides (TG), and Low-density lipoprotein cholesterol (LDL-C). These data will be analyzed using WinBUGS 1.4.3 and then visualized using Stata 14.0 software.RESULTSA total of 77 RCTs involving 7770 patients were included. The results indicated that Huazhi Rougan granules combined with WM (OR = 0.13, 95 % CI 0.05 ∼ 0.26) had a SUCRA probability value of 81.7 %, ranked first in clinical efficacy and significantly improved blood lipids levels including TG, High-density Lipoprotein Cholesterol (HDL-C), and LDL-C, Total cholesterol (TC). For the Chinese patent medicines alone, Danning tablets led with a 75.3 % clinical efficacy rate. Huazhi Rougan granules significantly increased levels of ALT (96.2 %) and AST (MD = -14.48, 95 % CI -23.38 ∼ -5.32). Dangfei Liganning capsules demonstrated significant efficacy in improving TG (73.1 %) and TC (83 %) levels.CONCLUSIONIn the treatment of NAFLD, the combination of Huazhi Rougan granules and WM demonstrated significant clinical effectiveness and improvement in blood lipid profiles. For different outcome indicators, Danning tablets used alone showed the highest clinical efficacy, while significant improvement in liver function indicators was best achieved with Huazhi Rugan granules used alone.

19 Nov 2024·Combinatorial Chemistry & High Throughput Screening

Huazhi Rougan Granule Alleviates Liver and Intestinal Damage in Non-Alcoholic Fatty Liver Disease by Regulating miR-122 Expression and TLR4/MyD88/NF-κB Pathway Activation

Article

Author: Li, Chan ; Lv, Kun ; Deng, Ming ; Xie, Ping ; Jin, Xiaowei

Purpose:miR-122 is upregulated in non-alcoholic fatty liver disease (NAFLD) liver tissue, and knockdown of miR-122 protects hepatocytes from lipid metabolism disorders. This study aimed to investigate whether Huazhi Rougan Granule (HRG) alleviates NAFLD liver and intestinal injury by regulating the miR-122-mediated TLR4/MyD88/NF-κB pathway.Methods:Rats with NAFLD were constructed by high-fat feeding. Serum levels of total cholesterol (TC), triglycerides (TG), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) were measured using a fully automated biochemical instrument. Histopathological changes in the liver and small intestine were observed by HE staining. QRT-PCR detected the expression level of miR-122 in the liver tissues. The protein expression of TLR4, MyD88, NF- κB p65, and p-p65 in liver tissues was detected by western blotting.Results:HRG slowed down the weight gain of NAFLD rats, decreased (P<0.05) the levels of TC, TG, ALT, AST, TNF-α, IL-1β, IL-6, LPS, and Hpt, improved the pathological status of liver and small intestine tissues, upregulated (P<0.05) the expression of ZO-1 and Occludin, downregulated (P<0.05) the protein expression of TLR4, MyD88, and p-p65, and inhibited (P<0.05) the expression of miR-122.Conclusion:HRG may alleviate hepatic and intestinal injuries in rats with NAFLD by regulating the miR-122-mediated TLR4/MyD88/NF-κB pathway.result:HRG slowed down the weight gain of NAFLD rats, decreased the levels of TC, TG, ALT, AST, TNF-α, IL-1β, IL-6, LPS and Hpt, improved the pathological status of liver and small intestine tissues, up-regulated the expression of ZO-1 and Occludin, down-regulated the protein expression of TLR4, MyD88 and p-p65, and inhibited the expression of miR-122.

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

[Huazhi Rougan Granules attenuates steatosis in cell model of nonalcoholic fatty liver disease by inducing autophagy].

Article

Author: Zhu, Chun-Sheng ; Li, Xiao-Ping ; Shi, Ya-Min ; Fu, Zhi-Hui

To investigate the effect of Huazhi Rougan Granules(HZRG) on autophagy in a steatotic hepatocyte model of free fatty acid(FFA)-induced nonalcoholic fatty liver disease(NAFLD) and explore the possible mechanism. FFA solution prepared by mixing palmitic acid(PA) and oleic acid(OA) at the ratio of 1∶2 was used to induce hepatic steatosis in L02 cells after 24 h treatment, and an in vitro NAFLD cell model was established. After termination of incubation, cell counting kit-8(CCK-8) assay was performed to detect the cell viability; Oil red O staining was employed to detect the intracellular lipid accumulation; enzyme-linked immunosorbnent assay(ELISA) was performed to measure the level of triglyceride(TG); to monitor autophagy in L02 cells, transmission electron microscopy(TEM) was used to observe the autophagosomes; LysoBrite Red was used to detect the pH change in lysosome; transfection with mRFP-GFP-LC3 adenovirus was conducted to observe the autophagic flux; Western blot was performed to determine the expression of autophagy marker LC3B-Ⅰ/LC3B-Ⅱ, autophagy substrate p62 and silent information regulator 1(SIRT1)/adenosine 5'-monophosphate(AMP)-activated protein kinase(AMPK) signaling pathway. NAFLD cell model was successfully induced by FFA at 0.2 mmol·L~(-1) PA and 0.4 mmol·L~(-1) OA. HZRG reduced the TG level(P<0.05, P<0.01) and the lipid accumulation of FFA-induced L02 cells, while elevated the number of autophagosomes and autophagolysosomes to generate autophagic flux. It also affected the functions of lysosomes by regulating their pH. Additionally, HZRG up-regulated the expression of LC3B-Ⅱ/LC3B-Ⅰ, SIRT1, p-AMPK and phospho-protein kinase A(p-PKA)(P<0.05, P<0.01), while down-regulated the expression of p62(P<0.01). Furthermore, 3-methyladenine(3-MA) or chloroquine(CQ) treatment obviously inhibited the above effects of HZRG. HZRG prevented FFA-induced steatosis in L02 cells, and its mechanism might be related to promoting autophagy and regulating SIRT1/AMPK signaling pathway.

100 Deals associated with Huazhi Rougan Granules

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Indication	Country/Location	Organization	Date
Fatty Liver	CN	Shandong New Time Pharmaceutical Co. Ltd.	26 Feb 2019

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