Graves' Disease
Conditions
Interventions
Treatment group:Bailing capsule combined with methimazole
control group:Methimazole
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following screening criteria would be eligible (1) Patients with Graves' disease, newly diagnosed patients or relapsed patients after drug withdrawal for more than one year; (2) TSH receptor antibody (TRAb) positive (> 1.75 IU/L); (3) Age of 18-65 years old (including 18 years old and 65 years old), regardless of gender; (4) Voluntarily participated in this clinical trial, informed consent and signed informed consent.
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) Peripheral blood white blood cell count < 3.0×10^9 / L or neutrophils <1.5×10^9/L; (5) Complicated with serious primary diseases of cardiovascular and cerebrovascular systems, liver, kidney, digestive and hematopoietic systems; (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 |
|---|---|
| Difference of TRAb titer from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of TRAb titer from baseline;The negative conversion rate of TRAb in patients;The first time of TRAb negative conversion;Difference of thyroid peroxidase antibody (TPOAb) titer from baseline;Difference of thyroid hormones (FT3, FT4, TSH) from baseline;Proportion of patients whose thyroid hormones returned to normal;The first normal time of thyroid hormone;Difference of thyroid volume from baseline;Difference of ThyPRO-39 score in the quality of life of patients from baseline;The dose of methimazole used;Difference of cytokines (TNF-a, IFN-?, IL-2, IL-4, IL-6, IL-10) from baseline.; | — |
Countries
China
Contacts
Public ContactZhao Jiajun
Shandong Provincial Hospital
Outcome results
None listed