ITMCTR2200006524尚未招募1 期
Randomized, controlled, double-blind, multicenter, prospective clinical study and mechanism exploration of Qinggan Sanjie Xiaoying Decoction in treating Hashimoto's thyroiditis
Sun Simiao Hospital of Beijing University of traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •(1)34 IU/ml < TPOAb < 600 IU/ml
- •(2)TGAb < 4000 IU/ml
- •(3)TRAB(-);
- •(4) Thyroid ultrasound showed diffuse enlargement or heterogeneous echo;
- •(5) 18 to 70 years old;
- •(6) Thyroid hormones (FT3, FT4, T3, T4) were within the reference range;
- •(7) Elevated levels of thyroid stimulating hormone (subclinical hypothyroidism);
- •(8) Drug washout period: no clinical trial, immune preparation and Chinese medicine were conducted within 3 months before enrollment;
- •(9) No drugs affecting thyroid hormone metabolism, including corticosteroids, preparations containing vitamins or trace elements, amiodarone a Interferons, lithium preparations, antidepressants or antipsychotics, etc;
- •(10) Did not participate in other clinical studies;
- •(11) I signed the informed consent to participate in this study.
排除标准
- •(1) Previous or current thyroid diseases, including nodular goiter, hyperthyroidism or subclinical hyperthyroidism, or history of thyroid surgery, radiation iodine therapy, Graves disease;
- •(2) Abnormal liver function (ALT and AST exceed the upper limit of normal value), abnormal renal function (Cr and BUN exceed the upper limit of normal value);
- •(3) Women who are pregnant, lactating or preparing for pregnancy;
- •(4) Serious systemic diseases, such as heart failure (NYHA grade III / IV), severe arrhythmia, unstable angina pectoris, and myocardial infarction within half a year; Acute stroke or severe sequelae, without cognitive ability or unable to take care of themselves and cooperate;
- •(5) Suffering from other immune system diseases;
- •(6) Suffering from malignant tumor;
- •(7) Allergic to the test drug;
- •(8) Surgery or other stress conditions, as well as mental illness, drug or other substance abuse.
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