NCT01551498已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabloc on Antithyroid Autoantibodies and Thyroid Function in Autoimmune Thyroiditis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 9
- 主要终点
- Numbers of subjects experiencing adverse effects as a measure of safety
研究概览
简要总结
This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.
详细描述
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18-70 years of age
- •having positive antibodies against thyroid peroxidase
- •having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis
排除标准
- •having evidence of end-stage thyroiditis
- •being a current smoker or smokeless tobacco user
- •be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody
- •be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent
研究组 & 干预措施
Placebo
Placebo Comparator
subject takes one oral placebo lozenge, three times per day
干预措施: Placebo (Dietary Supplement)
Anatabloc Supplement
Active Comparator
subject takes one oral Supplement lozenge, three time per day
干预措施: Anatabloc Supplement (Dietary Supplement)
结局指标
主要结局
Numbers of subjects experiencing adverse effects as a measure of safety
时间窗: 3 months
Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects
次要结局
- Measured changes in markers of autoimmune thyroiditis: changes in blood levels of anti-thyroid auto-antibodies, and changes in the volume and vascularization of the thyroid(3 months)
研究者
研究点 (9)
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