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Open Access 01-12-2019 | IgA Vasculitis | Study protocol

Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial

Authors: Ying Ding, Xia Zhang, Xianqing Ren, Wensheng Zhai, Liyun He, Jianping Liu, Chen Yao, Shanshan Han, Long Wang

Published in: Trials | Issue 1/2019

Abstract

Background

Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes guidelines; however, this approach may lead to undertreatment, especially in patients with persistent proteinuria that does not reach nephrotic levels and/or hematuria and those with a pathological classification between grades 1 and 3 according to the International Study of Kidney Disease in Children. This study was performed to evaluate the curative effect and safety of a traditional Chinese medicine (TCM) integrated treatment program in this type of HSPN.

Methods

This multicenter, open-label, large-sample, randomized controlled trial was performed in China and included 500 children with HSPN exhibiting mild pathological patterns. The treatment group to control group ratio was 2:1, and each group was further stratified into two types, light and heavy, according to urinary protein quantification and pathological type. The treatment group received tripterygium glycosides (TGs), tanshinone IIa sodium sulfonate injection, and Chinese herbs selected based on syndrome differentiation in TCM. The heavy and light subgroups received treatment courses and dosages of TG. In the control groups, the light group received benazepril hydrochloride tablets, low molecular weight heparin calcium injection, dipyridamole tablets, and a Chinese medicine placebo, while the heavy group received the same treatment plus prednisone. All groups were treated for 3 months and then followed up for 9 months. The efficacy and safety of the treatments were then evaluated among the groups.

Discussion

Currently, few treatments are available for HSPN patients with mild pathological patterns indicating light to moderate proteinuria and/or hematuresis. In this large-sample study, we provide a new approach for HSPN that includes an integrated treatment program that incorporates TCM.

Trial registration

Clinical Trials.gov, NCT03591471. Re-registered on 19 July 2018.

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Title: Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial
Authors: Ying Ding
Xia Zhang
Xianqing Ren
Wensheng Zhai
Liyun He
Jianping Liu
Chen Yao
Shanshan Han
Long Wang
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: IgA Vasculitis
IgA Vasculitis
Key Symptom
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3484-3

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Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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