研究疾病:
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桥本甲状腺炎
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研究疾病代码:
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Target disease:
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Hashimoto's thyroiditis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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本研究采用随机、对照、双盲、多中心、前瞻性临床研究方法,进一步确认清肝散结消瘿方治疗桥本甲状腺炎减低TPOAb滴度的临床疗效,并通过多种组学技术揭示其临床疗效的内在机制。
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Objectives of Study:
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In this study, a randomized, controlled, double-blind, multicenter, prospective clinical study method was adopted to further confirm the clinical efficacy of Qinggan Sanjie Xiaoying recipe in treating Hashimoto thyroiditis and reducing TPOAb titer, and to reveal the internal mechanism of its clinical efficacy through a variety of omics techniques.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)34 IU/ml < TPOAb < 600 IU/ml;
(2)TGAb < 4000 IU/ml;
(3)TRAB(-);
(4)甲状腺超声提示弥漫性肿大或不均质回声;
(5)18至70岁;
(6)甲状腺激素(FT3、FT4、T3、T4)在参考范围内;
(7)含促甲状腺激素水平升高(亚临床甲状腺功能减退症);
(8)药物洗脱期:入组前3个月内未进行临床试验、免疫制剂、中药;
(9)未使用影响甲状腺激素代谢药物,包括皮质类固醇、含有维生素或微量元素的制剂、胺碘酮、α干扰素、锂制剂、抗抑郁剂或抗精神病药物等;
(10)未参与其他临床研究;
(11)签署知情同意书愿意参加本项研究。
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Inclusion criteria
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(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 α 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.
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排除标准:
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(1)既往或现患甲状腺其他疾病,包括结节性甲状腺肿、甲亢或亚临床甲亢,或有甲状腺手术史和放射碘治疗史、Graves病;
(2)肝功能异常(ALT、AST超过正常值上限)、肾功能异常(Cr、BUN超过正常值上限);
(3)妊娠期、哺乳期、正在备孕的女性;
(4)严重的系统性疾病,如:心衰(NYHA分级为III/IV级)、严重心律失常、不稳定型心绞痛,半年内曾发生心肌梗塞;急性脑卒中或遗留有严重后遗症,没有认知能力或生活不能自理及不能合作者;
(5)患其他免疫系统疾病;
(6)患恶性肿瘤;
(7)对试验药物过敏者;
(8)手术或其他应激情况以及有精神性疾患、药物或其他物品滥用者。
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Exclusion criteria:
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(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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研究实施时间:
Study execute time:
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从From
2022-08-22
至To
2022-06-30
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征募观察对象时间:
Recruiting time:
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从From
2022-08-22
至To
2023-03-31
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