Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05043233
Eligibility Criteria:
Inclusion Criteria:
Patients aged 18-70 years old with normal BMI (18-25), who are diagnosed with Graves' disease hyperthyroidism in accordance with the 2016 American Thyroid Association's guidance at the first diagnosis, or patients who relapse after more than one year of medication withdrawal.
1. High metabolic symptoms such as fear of heat, sweating, and palpitations;
2. Diffuse enlargement of thyroid gland, B-ultrasound of thyroid gland indicates diffuse thyroid disease and increased blood flow of thyroid;
3. Serological detection of TSH levels decreased and FT3 and/or FT4 increased; meanwhile, TRAb was positive (TRAb\>1.75 IU/L);
4. Accompanied by thyroid infiltrating ocular signs or pretibial mucous edema.
Exclusion Criteria:
1. Patients with Graves' disease who have previously undergone radioactive iodine 131 or surgery;
2. Blood routine WBC\<3×109/L, neutrophils\<1.5×109/L, or accompanied by other malignant blood diseases;
3. Patients with other serious heart, liver, lung, kidney disease or malignant tumors;
4. In the past six months, there is a history of using immunosuppressants or other autoimmune diseases such as systemic lupus erythematosus, Sjogren's syndrome, etc.;
5. Pregnant and lactating women; Allergies to the drugs used in the treatment plan; and any situation (medical, psychological, social, or geographical factors) that may endanger the safety of the patient or prevent the patient from successfully participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05043233
Study Brief:
Protocol Section:
NCT05043233