Name of Investigational Products Huangkui capsule.
Trial Topic A Randomized, Double-blinded, Parallel, controlled, Multicenter Clinical Trial of Huangkui Capsule in Treating Type II Diabetic Nephropathy (DKD)
Trial Objectives Primary objective:To evaluate HuangKui capsule efficacy for treatment of type II diabetes ACR.
Secondary objective: To evaluate the efficacy of HuangKui capsule on 24-hour urinary protein changes、reduce PCR-increase eGFR, improve micro-inflammatory state, and improving Traditional Chinese medicine clinical efficacy
Trial Design Designed as a block randomized, double-blinded, parallel controlled, multi-center clinical trial.

Start Date01 Jan 2017

Sponsor / Collaborator

Jiangsu Famous Medical Technology Co., Ltd

NCT02231125 / Unknown statusPhase 4IIT

Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial

-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.

Start Date01 Sep 2014

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

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100 Clinical Results associated with Abelmoschus manihot extract

100 Translational Medicine associated with Abelmoschus manihot extract

100 Patents (Medical) associated with Abelmoschus manihot extract

Literatures (Medical) associated with Abelmoschus manihot extract

31 May 2024·Medicine

Efficacy and safety of Huangkui capsule for diabetic nephropathy: A systematic review and meta-analysis

Review

Author: Liu, Shilin ; Song, Chaoqun ; Wu, Cui ; Li, Yuandong ; Nan, Zheng

Background:To systematically evaluate the efficacy and safety of Huangkui capsule (HKC) in the treatment of diabetic nephropathy (DN).Methods:A computerized search of 8 online databases, CNKI, VIP, WANGFANG, CBM, ChiCTR, Embase, PubMed, and Cochrane Library, was conducted from the time of database construction to June 23, 2023, and randomized controlled trials of HKC for the treatment of DN were included according to the predefined screening criteria. Literature quality was evaluated with the help of Cochrane Risk of Bias Assessment Tool, and data were analyzed by STATA/MP17 and RevMan 5.3 software.Results:A total of 1543 articles were retrieved, and 45 studies were finally included, all in Chinese, with a total sample size of 4297 cases, including 2168 cases in the experimental group and 2129 cases in the control group, and the quality of all the included studies was generally low. Meta-analysis showed that (1) efficacy: effective rate: [relative risk = 1.24, 95% confidence interval (CI) (1.20, 1.29), P < .001], SCR: [standard mean difference (SMD) = −1.19, 95% CI (−1.47, −0.91), P < .001], 24 h-UTP: [SMD = −1.27, 95% CI (−1.66, −0.88), P < .001]. Other renal function, glucose metabolism, lipid metabolism, and inflammatory factors related indicators improved compared with the control group. But in the outcome index of estimated glomerular filtration rate, the addition of HKC did not have an advantage over conventional treatment alone. Estimated glomerular filtration rate: [SMD = −0.21, 95% CI (−0.80, 0.39), P = .50]. (2) Safety: There was no statistical significance in the incidence of adverse reactions between the study group with the addition of HKC and the control group.Conclusion:The clinical efficacy and safety of DN treated with the combination of HKC is better than that of conventional western medicine alone, but to better evaluate the efficacy and safety of HKC as an adjunctive intervention for DN, more rigorously designed large-sample, multicenter randomized controlled trials are needed to provide evidence support in the future.

01 Jan 2024·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Clinical metabolomics of Zicuiyin in treatment of diabetic kidney disease].

Article

Author: Zhang, Zhi-Dan ; Huang, Yu-Hong ; Lyu, Chun-Xiao ; DU, Xi ; Liu, Jia

This study aimed to analyze the therapeutic effect of Zicuiyin on diabetic kidney disease(DKD) and explore the possible targets of this formula. Eighteen DKD patients treated in the endocrine department or nephrology department of Second Affilia-ted Hospital of Tianjin University of Traditional Chinese Medicine from January to December in 2019 were enrolled and assigned into a test group(n=10) and a control group(n=8). Both groups received routine chemical medicine treatment. In addition, the test group was treated with Zicuiyin and the control group with Huangkui Capsules for 8 weeks. The clinical trial was approved by the Ethics Committee of Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, with the ethical approval No. 2017-023-01, and all the patients signed the informed consent form. The results showed that the 8-week treatment with Zicuiyin lowered the level of glycosylated hemoglobin(HbA1c) and recovered the 24 h urinary protein(24hUP), 24 h urinary microalbumin(24hmAlb), urine albumin-to-creatinine ratio(UACR), and estimated glomerular filtration rate(eGFR) of the patients with 24hUP<3.5 g. According to the different levels in 24hUP, all the patients were divided into two subgroups(subgroup A with 24hUP<3.5 g and subgroup B with 24hUP≥3.5 g). The ultra-high performance liquid chromatography-quadrupole-time-of-flight tandem mass spectrometry(UPLC-Q-TOF-MS/MS)-based non-targeted metabolomics analysis was conducted on the baseline serum samples from diffe-rent subgroups of patients. Nineteen biomarker candidates were identified to distinguish the metabolic differences between the two subgroups, and their correlations with clinical indicators were analyzed. Zicuiyin lowered the levels of phenylalanine, pseudouridine, and adenosine [fold change(FC)<0.5, P<0.05] in subgroup A. The results indicated that Zicuiyin was more effective on the DKD patients with low urinary protein levels, and its targets were involved in phenylalanine metabolism and nucleoside metabolism.

01 Dec 2023·Biomedicine & Pharmacotherapy

Effects of total flavones of Abelmoschus manihot (L.) on the treatment of diabetic nephropathy via the activation of solute carriers in renal tubular epithelial cells

Article

Author: Qiang, Lei ; Wang, Mei ; Gu, Harvest F ; Tang, Haitao ; Xu, Qing ; Yu, Jinshi ; Yu, Hongmei ; Tang, Wei ; Ge, Haitao

As a traditional Chinese medicine, Huangkui capsule (HKC) has been used to treat patients with kidney diseases, including diabetic nephropathy (DN). We have recently demonstrated that HKC could re-regulate the activities of solute carriers (SLC)s in proximal and distal convoluted tubules of kidneys in regression of the development of DN. The main active chemical constituents of HKC are the flavones of Abelmoschus manihot (L.). The current study aims to further evaluate the efficacy of total flavones of A. manihot (TFA) in the regression of DN by analyzing SLC activities in proximal and distal convoluted tubules of kidneys. TFA (0.076 g/kg/d) or vehicle was administered in db/db mice, the animal model of type 2 diabetes and DN, daily via oral gavage for four weeks. Blood glucose levels and urinary albumin-to-creatinine ratio (UACR) were measured and used for the determination of T2D and DN. Ten SLCs, including slc2a2, slc4A1, slc5a2, slc5A3, slc5a8, slc6a20, slc27a2, slc12a3, slc34a1 and slc38a2 were highly expressed in proximal and distinct convoluted tubules of kidneys. Their expression at mRNA and protein levels before and after TFA treatment were analyzed with real-time RT-PCR and immunohistochemistry. Data showed that UACR in the db/db mice after TFA treatment was significantly decreased. Compared with the group of non-diabetic control, slc2a2, slc4A1, slc5a2, slc5A3, slc5a8, slc6a20, slc27a2, slc12a3, slc34a1 and slc38a2 in the group of DN were down-regulated but up-regulated after TFA treatment. Further analyses of whole kidney sections indicated that the numbers and structures of the nephron in db/db mice was increased and improved after TFA treatment. Thereby, the current study provides further evidence that the flavones in A. manihot have pharmacological effects on the treatment of DN by improving the biological function of SLCs in kidneys.

100 Deals associated with Abelmoschus manihot extract

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Indication	Country/Location	Organization	Date
Chronic nephritis	CN	SZYY Group Pharmaceutical Ltd.	07 Jul 2020

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