NCT03281486已完成不适用
Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes
You First Services2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Relief from drymouth using VAS scoring
研究概览
简要总结
An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be above 18 years of age.
- •Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.
- •Ability to attend visits at the research site
- •Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
- •Agree to abstain from the use of any products for xerostomia other than those provided in the study.
- •Agree to comply with the conditions and schedule of the study.
排除标准
- •Subjects with open mouth sores at study entry.
- •Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.
- •Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
- •Subjects currently on medication or treatment for dry mouth/xerostomia
- •Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
- •Subjects with soft or hard tissue tumor of the oral cavity.
- •Presence of severe gingivitis.
- •Chronic disease with concomitant oral manifestations other than xerostomia
- •History of radiation therapy to head and neck
- •Subjects with conditions the investigator may feel will interfere with the study.
结局指标
主要结局
Relief from drymouth using VAS scoring
时间窗: 9 weeks
Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring
次要结局
未报告次要终点
研究者
研究点 (2)
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