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

This study was performed to evaluate the curative effect and safety of a traditional Chinese me dicine (TCM) integrated treatment program in this type of HSPN.MethodsThis 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.DiscussionCurrently, 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 registrationClinical ...
Source: Trials - Category: Research Source Type: clinical trials