Hashimoto's Thyroiditis
Conditions
Interventions
Yupingfeng Tea Bag Group:Yupingfeng Tea Bag
Control group:Selenium yeast tablet
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, and <= 65 years old; gender not restricted; 2. Clinical diagnosis of Hashimoto's thyroiditis with the following: (1) serum TPOAb more than 2 times the upper limit of normal and elevated TGAB levels; (2) normal thyroid function or primary subclinical hypothyroidism (normal TT4, FT4, 2 times the upper limit of normal reference value TSH <= 20 mU/L); 3. Chinese medicine diagnosis of spleen-lung qi deficiency; 4. Patient voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous use of other immunomodulators within 3 months; 2. Having taken medication within 3 months that affect thyroid function (e.g. anti-thyroid drugs, thyroxine, etc.); 3. In combination with other thyroid disorders such as Graves' disease, subthyroiditis, HT causing transient hyperthyroidism, severe mucinous oedema, thyroid cancer or highly suspected thyroid cancerous changes; 4. Persons with grade III goitre; 5. Individuals with known immunocompromised status, including but not limited to those who have undergone organ transplantation or acquired immunodeficiency syndrome (AIDS); 6. Individuals with severe vitamin D deficiency: 25(OH)VitD = 180 mmHg and/or diastolic blood pressure>=110 mmHg; patients with systolic blood pressure 8.0% ; 9. Patients with clinically significant hepatobiliary disease, including but not limited to, chronic active hepatitis and/or severe hepatic insufficiency, cirrhosis. Glutamic aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) > 3 times the upper limit of normal (150 U/L) or serum total bilirubin (TB) > 34.2 µmol/L (> 2 mg/dL); 10. Patients with a history of renal disease or features associated with the renal disease that is (1) History of unstable or rapidly progressive renal disease. (2) Patients with moderate/severe renal impairment or end-stage renal disease: estimated glomerular filtration rate (eGFR) <60mL/min/1.73m2. 11. Any of the following cardiovascular diseases within the last 6 months: (1) Myocardial infarction; (2) Cardiac surgery or revascularization (coronary artery bypass grafting/percutaneous transluminal angioplasty) (3) Unstable angina pectoris; (4) Congestive heart failure (New York Heart Association class III or IV); (5) Transient ischaemic attack or significant cerebrovascular disease; 12. History of acute or chronic infection, surgery or severe trauma within the last 3 months; 13. Current cardiovascular, renal, hepatic, haematological, oncological, endocrine, psychiatric or rheumatic disease judged by the investigator to be unstable or severe; 14. A history of drug abuse, alcoholism or drug addiction within the past 6 months; 15. Subjects who, in the judgment of the investigator, are unlikely to comply with the protocol, patients with serious physical or psychological illnesses that may affect efficacy or safety; 16. Patients with allergies or hypersensitivity to known components of this test drug, those with Chinese medical evidence of yin deficiency or damp-heat.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ThyPRO39 questionnaire score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for symptoms to disappear;TSH Recurrence Rate;Changes in TSH;level of TPOAb;level of TgAb;Serum inflammatory factor levels;Lipid profile;Thyroid volume and isthmus thickness; | — |
Countries
China
Contacts
Public ContactSiyuan Zheng
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed