Evaluation of the safety and efficacy of tripterygium wilfordii glycosides for patients with  primary sjgren's syndrome : protocol for a prospective, double-blinded, randomized, placebo-controlled clinical trial

Abstract

Background: As a common autoimmune disease, primary sjogren's syndrome(pss) has limited therapeutic agents. For some patients with Sjogren's syndrome complicated with serious complications, taking glucocorticoid combined with cyclophosphamide treatment can obtain good results. However, the side effects of long-term use of glucocorticoid and cyclophosphamide limit its application in patients without extraglandular manifestations. Some animal experiments have shown that tripterygium wilfordii polyglycosides tablets have immunomodulatory effects. The immunomodulatory function of Tripterygium polyglucoside was found in some animal experiments. Some Single center, small sample, non-randomized control studys have proved that tripterygium wilfordii glycosides can allevitate dry eye,dry mouth and serological immunological abnormalities in the patients with PSS .Therefore, we designed this research to study the effect of tripterygium wilfordii glycosides for patients with  primary sjgren's syndrome by measuring the reduction of serum globulin,IgA、IgG、IgM、TNF – α，as well as the extent of dry eye and mouth. 

Methods : This study is a 12-week, single-center, prospective, double-blinded, randomized, placebo-controlled clinical trial developed from July 2022 to December 2023. Forty individuals with Primary Sjögren’s syndrome without extraglandular manifestations will be recruited and randomly assigned to receive tripterygium wilfordii glycosides or a placebo，and each group will have 20 subjects. During the 12-week observation period, there will be 4 visits. The decline in serum immunoglobulin IgG, IgM, IgA and tumor necrosis factor –α is the main outcome measure, and change of dry mouth, dry eye : Natural saliva flow rate、Schirmer's test、Tear break-up time and Adverse reactions: damage of blood system, liver and kidney function are the secondary outcome measures. 

Discussion:  This study will probe the effect of tripterygium wilfordii glycosides in the treatment of pSS and explore possible therapeutic mechanisms. By performing this trial, we hope to provide evidence and data to support further large clinical studies. 

Trial registration: Chinese Clinical Trial Registry ChiCTR2200062262. Registered on 31 July 2022.http://www.chictr.org.cn/edit.aspx?pid=175924&htm=4 

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