A Natural Formulation for Patients Diagnosed With Xerostomia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Salivary Flow From Baseline
研究概览
简要总结
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia. The major component of this formulation is green tea extract with a defined composition of polyphenols. Epidemiological studies suggest that phytochemicals in green tea possess beneficial effects on autoimmune and inflammatory diseases. Thus far, there is little evidence to indicate any marked and direct immunomodulatory effect of green tea on T or B lymphocytes. However, there is considerable evidence for green tea polyphenols (GTPs), major phytochemicals found in green tea extract, having properties consistent with effects on cells of tissues that would be protective towards local inflammation.
详细描述
Patients with subjective complaints of xerostomia will be given a screening questionnaire to complete. If they meet the criteria on this screening form, the research coordinator will be notified and will meet with the patient either immediately or at a scheduled follow-up appointment. The research coordinator will review the information and then explain the details of the study to the patient and obtain informed consent. Once the patient has signed the informed consent, the research coordinator will collect the demographic, medical history, and contact information from the patient. Any information missing will be noted for follow-up investigation by the research coordinator. If a subject is of child bearing age, they will be asked to complete a urine pregnancy test prior to enrollment.[a] First appointment -Screening, consent. [b]Follow appointments- review, then Patients will do VAS questionnaire, QOL questionnaire, Sialometry will be done measuring unstimulated whole saliva and Stimulated whole saliva for 5 min each.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS)
- •Clinical Diagnosis of primary or secondary Sjogren's syndrome.
- •Over the age of
- •Taking less than three drugs associated with causing xerostomia or salivary gland hypofunction.
- •Willing to use natural novel topical dry mouth products.
- •Prior minor salivary gland biopsy and serology from Sjogren's Syndrome/Xerostomia work-up.
- •Willing to return for all study-associated visits.
- •Able to read, understand, and sign the informed consent.
排除标准
- •Have received radiation to the head and neck region.
- •Unable to read and understand the consent form.
- •On greater than three drugs associated with xerostomia or salivary gland hypofunction.
- •Require dento-alveolar surgery or extensive dental treatment during the course of the study.
- •Require hospitalization for any medical problem during the course of the study.
- •Unable to take green tea leaf extract and/or pilocarpus jaborandi leaf extract and/or xylitol because of allergy
- •Uncontrolled medical conditions that require changes in medication during the course of the study.
- •Regularly consume green tea and/or components of pilocarpus jaborandi.
- •Are pregnant
结局指标
主要结局
Change in Salivary Flow From Baseline
时间窗: 8 weeks
Change in salivary flow in Xerostomic patients using Green tea lozenges
次要结局
未报告次要终点
研究者
Scott DeRossi
Chairman, Diagnostic Sciences
Augusta University