Randomized, controlled, double-blind, multicenter, prospective clinical study and mechanism exploration of Qinggan Sanjie Xiaoying Decoction in treating Hashimoto's thyroiditis
- Conditions
- Hashimoto's thyroiditis
- Registration Number
- ITMCTR2200006524
- Lead Sponsor
- Sun Simiao Hospital of Beijing University of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TPOAb;
- Secondary Outcome Measures
Name Time Method TGAb;TSH;ultrasound;T4;ThyPRO39;T3;FT4;FT3;