Hashimoto Thyroiditis
Conditions
Interventions
Control group:Levothyroxine Sodium
Test group:Bailing Capsule combined with Levothyroxine Sodium
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Hashimoto Thyroditis; 2. Serum thyroid peroxidase antibody(TPOAb) is positive, TPOAb>300IU/ml; 3. Patients with hypothyroidism or subclinical hypothroidism who require L-T4 replacement therapy (When hypothyroidism occurs in HT patients, or subclinical hypothyroidism, TSH>10mIU/L, or 10mIU/L = TSH>4 mIU/L and obvious clinical symptoms, need to supplement thyroid hormone ) 4. Age of 18-65 years old (including 18 years old and 65 years old), regardless of gender; 5. Voluntarily participated in this clinical trial, informed consent and signed informed cosent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be admitted to this trial (1) Patients with the following history of nephropathy or nephrology-related characteristics: patients with moderate/severe kidney injury or end-stage renal disease: estimated glomerular filtration rate (eGFR, calculated using the simplified MDRD formula: eGFR=186×(Scr)^-1.154×(age)^-0.203×(0.742 female))3 times the upper limit of normal or serum total bilirubin (TB)>34.2µmol/L (> 2mg/dL); (3) Grade 2 hypertension patients: diastolic blood pressure =100 mmHg, systolic blood pressure =160 mmHg; (4) Severe vitamin D deficiency: 25 (OH) VitD8.0%;; (6) Patients with other thyroid diseases, such as subacute thyroiditis and high-function adenoma; (7) Patients with other autoimmune diseases; (8) early hyperthyroidism crisis and hyperthyroidism crisis; (9) Previous history of thyroid radioactive iodine therapy or surgery; (10) Patients who have taken glucocorticoids or other immunosuppressants within the last 1 month; (11) Patients who have taken cordyceps preparations in the last 3 months; (12) Patients who have taken drugs that may affect antibody titers, such as selenium supplementation or other traditional Chinese medicines, within the last 1 month; (13) History of allergy to experimental drug ingredients; (14) A long history of alcohol and drug abuse; (15) Patients who having mental retardation or mental disorder; (16) Women who are pregnat or lactating or women can not be on strictly contraception during the trial; (17) Participated in other clinical trials in the past 3 months; (18) The investigator considered the patients inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of Anti-TPOAb titer from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of Anti-TgAb titer from baseline;The change of thyroid hormones (FT3, FT4, TSH) from baseline;The change of thyroid volume;The change of ThyPRO-39 score in the quality of life of patients from baseline;The change of cytokines (TNF-a, IFN-?, IL-2, IL-4, IL-6, IL-10) from baseline;The change of dosage of basic therapeutic drugs; | — |
Countries
China
Contacts
Public ContactJiajun Zhao
Shandong Provincial Hospital
Outcome results
None listed