ChiCTR2000033420Active, not recruitingEarly Phase 1
西维美林对改善早期舍格伦综合征症状的临床疗效评价
徐州医科大学附属淮安医院口腔科1 site in 1 country66 target enrollmentStarted: June 1, 2020Last updated:
Interventions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- 唾液分泌量
Study Overview
Brief Summary
通过在原发性舍格伦综合征（primary Sjogren Syndrome，pSS）患者中使用西维美林作为促腺体分泌剂，研究其在改善 pSS 症状和体征中的临床疗效。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- 试验中患者、检查者和统计分析者均不知患者所服用药物种类，所有试验数据待统计学分析完成后予以揭盲。
Eligibility Criteria
- Ages
- 18 to 55 (—)
- Sex
- All
Inclusion Criteria
- •（1）符合 American-European Consensus Group（AECG，2002）标准；
- •（2）无呼吸、心血管、消化系统疾病或病情经治疗处于稳定状态。
Exclusion Criteria
- •（1）近一个月使用 M 胆碱受体激动剂或抑制细胞色素药物；
- •（3）孕期或哺乳期内；
- •（4）合并其他部位自身免疫性疾病。
Arms & Interventions
对照组
安慰剂
试验组
西维美林
Intervention: 西维美林
Outcomes
Primary Outcomes
唾液分泌量
泪液分泌量
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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