DRYLESS: Randomized Controlled Trial of EVADRY® vs Placebo in the Treatment of Xerostomia in Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 主要终点
- salivary flow rate (SFR)
研究概览
简要总结
Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test.
详细描述
Study design:
This is a randomized controlled double-blind clinical trial involving 2 groups:
- Group 1: consisting of 90 patients receiving the EVADRY dietary supplement treatment.
- Group 2: consisting of 90 patients receiving a placebo
Inclusion and exclusion criteria:
• Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •diagnosis of Sjogren's syndrome according to ACR/EULAR 2016 criteria
- •continuous xerostomia for more than 3 months
- •initial salivary flow rate < 0.1 ml/min
排除标准
- •Occurrence of cognitive or dementia disorders
- •Pregnancy
- •Allergy to any of the components of the EVADRY product
- •Indication of oral or throat surgery
研究组 & 干预措施
EVADRY
90 Sjogren's syndrom patients with objective xerostomia receiving the EVADRY dietary supplement treatment.
干预措施: EVADRY (Dietary Supplement)
PLACEBO
90 Sjogren's syndrom patients with objective xerostomia receiving a placebo.
干预措施: Placebo (Other)
结局指标
主要结局
salivary flow rate (SFR)
时间窗: at inclusion, after 1, 2 and 3 months
It consists of asking the patient to collect their saliva in the morning without prior stimulation (no smoking, chewing gum, or alcohol one hour before) in a graduated tube for 15 minutes. The patient should be comfortably seated with their head slightly tilted forward and their mouth open to allow saliva to flow. A value less than 0.1 ml/minute corresponds to hyposalivation.
次要结局
- Xerostomia Inventory in French version(at inclusion, after 1, 2 and 3 months)
- Oral Health-related quality of life (OHIP-14) questionnaire(at inclusion, after 1, 2 and 3 months)
- Hospital anxiety and depression (HAD) scale(at inclusion, after 1, 2 and 3 months)
- Buccal Schirmer test(at inclusion, after 1, 2 and 3 months)
研究者
Fatma Said
Associate professor
University Tunis El Manar