[Translation] A randomized, double-blind phase IIa clinical study to evaluate the efficacy and safety of Songge Jiangniangsuan Granules in the treatment of hyperuricemia (damp-heat accumulation syndrome\phlegm turbidity obstruction syndrome)

初步评价松葛降尿酸颗粒治疗高尿酸血症（湿热蕴结证\痰浊阻滞证）的有效性和安全性。

[Translation]

To preliminarily evaluate the efficacy and safety of Songge Jiangni Acid Granules in the treatment of hyperuricemia (syndrome of damp-heat accumulation\syndrome of phlegm and turbidity obstruction).

Start Date01 Nov 2019

Sponsor / Collaborator

Ningbo Taikang Taxus Bioengineering Co., Ltd.

[+2]

100 Clinical Results associated with Songge Jiangniaosuan Granules

100 Translational Medicine associated with Songge Jiangniaosuan Granules

100 Patents (Medical) associated with Songge Jiangniaosuan Granules

Literatures (Medical) associated with Songge Jiangniaosuan Granules

01 Apr 2023·Contemporary Clinical Trials Communications

Evaluation the effectiveness of the Jiangniaosuan formulation in the treatment of hyperuricemic nephropathy in patients with chronic kidney disease stages 3–4: Study protocol of a randomized controlled trial

Article

Author: Zhou, Jiabao ; Xu, Li ; Wang, Yating ; Gao, Jiandong ; He, Yikun ; Wang, Chuanxu ; Xin, Jiadong ; Shen, Jiaying ; Lu, Lili ; Pan, Xin

BackgroundHyperuricemic nephropathy is a highly prevalent kidney disease induced by excessive accumulation and deposition of monosodium urate in kidney, which contributes to the loss of kidney function. The Jiangniaosuan formulation (JNSF) is a Chinese herbal medicine treatment. The aim of this study is to evaluate its efficacy and safety among patients with hyperuricemic nephropathy at chronic kidney disease (CKD) stages 3-4 and with obstruction of phlegm turbidity and blood stasis syndrome.MethodsOur research is designed as a single-centre, double-blinded, randomized, placebo-controlled trial for 118 patients diagnosed with hyperuricemic nephropathy at CKD stages 3-4 and with obstruction of phlegm turbidity and blood stasis syndrome in mainland China. Patients are to be randomized into two groups: either the intervention group which receives JNSF 20.4 g/day combined with febuxostat 20-40 mg/day, or the control group which receives JNSF placebo 20.4 g/day combined with febuxostat 20-40 mg/day. The intervention will be carried on for 24 weeks. The change in estimated glomerular filtration rate (eGFR) is set as the primary outcome. Secondary outcomes include changes in serum uric acid, serum nitric oxide, urinary albumin/creatinine ratio, urinary N-acetyl-β-D glucosaminidase, urinary β2 microglobulin, urinary retinol binding protein and TCM syndromes in 24 weeks. Statistical analysis will be formulated by SPSS 24.0.DiscussionThe trial will conduce to the comprehensive assessment in the efficacy and safety of JNSF among patients diagnosed with hyperuricemic nephropathy at CKD stages 3-4, and provide a clinical method available on systems of the combination of modern medicine and TCM.

01 Dec 2022·TrialsQ4 · MEDICINE

Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial

Q4 · MEDICINE

ArticleOA

Author: Gao, Jiandong ; Guo, Yafang ; Zhang, Changming ; Li, Dongdong ; Lu, Hong ; Gan, Jing

AbstractBackgroundJiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.MethodsA total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine, i.e., febuxostat 40 mg (WG group; n = 24), or Chinese herbal medicine, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG group; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24) still will receive febuxostat 20 mg + Jiangniaosuan formula, and the other group (JNSG; n = 24) will continue to receive Jiangniaosuan formula + placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in traditional Chinese medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.DiscussionWe hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.DisseminationThe results will be published in a peer-reviewed journal and disseminated by academic conferences. The datasets analyzed during the current study are available from the corresponding author on reasonable request.Trial registrationChinese Clinical Trials Register ChiCTR2000041083. Registered on 3 May 2021. The protocol version number is V3.0, 20210301.

100 Deals associated with Songge Jiangniaosuan Granules

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hyperuricemia	Phase 2	CN	Zhejiang University of Technology	01 Nov 2019
Hyperuricemia	Phase 2	CN	Ningbo Taikang Taxus Bioengineering Co., Ltd.	01 Nov 2019
Hyperuricemia	Phase 2	CN	Zhejiang Chinese Medical University	01 Nov 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Songge Jiangniaosuan Granules

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation