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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05461820
Eligibility Criteria:
Inclusion Criteria:
* Graves hyperthyroidism (responsible for doctors' clinical diagnosis)
* Age 18-65, for both men and women
* Thyroid receptor antibody (TRAb) was positive
* Take part in this research voluntarily and sign the informed consent form
Exclusion Criteria:
* Those who have used glucocorticoid or other immunosuppressants for a long time within 3 months before being selected
* Those who have participated in any other drug trials within 3 months before being selected
* Subjects who are participating in clinical research of other drugs
* Patients with a history of malignant tumors
* Ill-controlled hypertension: diastolic blood pressure≥100mmHg, systolic blood pressure ≥160 mmHg
* Blood routine: the total number of white blood cells \< 3.0×109 or neutrophils \< 1.5× 109
* Other thyroid diseases: such as subacute thyroiditis, thyroid nodules, high-function adenoma
* Alanine aminotransferase(ALT) or aspartate amino transferase(AST) is greater than 2 times of the normal upper limit; When ALT or AST is less than 2 times of the normal upper limit, and the test of hepatitis B two half-and-half positive
* Renal insufficiency: serum creatinine is higher than the upper limit of normal value
* Patients with heart failure
* Patients with coronary heart disease
* Patients with other autoimmune diseases
* Patients who are known to be allergic to any component of this medicine are allergic to the active ingredients or any auxiliary materials in the prescription
* Patients with multiple drug allergies, allergic diseases, people with high sensitivity and drug addicts
* Alcoholism, mental disorder or other observers who are not suitable for drug testing
* Pregnant and lactating women cannot rule out the possibility of pregnancy
* Taking any medicine with unknown ingredients or using traditional Chinese medicine, the researcher judges the medicine that may affect the curative effect of hyperthyroidism
* According to the researcher's judgment, other medical history that reduces the possibility of joining the group or complicates the joining of the group, such as frequent changes in the working environment, may easily lead to lost follow-up.
Rejection Criteria:
* The compliance of this clinical trial protocol is \< 80% or \> 120%;
* Those who did not meet the inclusion criteria or the exclusion criteria were found during the experiment;
* Those who can't cooperate, including those who can't complete the whole course of treatment, don't complete the follow-up as planned, and increase or decrease adjuvant drugs at will;
* During the trial, use other drugs that may affect the curative effect of this trial.
Termination of Research Criteria:
* Those who are allergic or intolerant to this drug;
* Adverse reactions or serious adverse events that patients can't tolerate occur;
* Pregnant women of childbearing age in the experiment;
* Other diseases appear during the treatment, and the treatment of accompanying diseases will interfere with the clinical observers of this medicine;
* The researcher thinks it is inappropriate to continue the experiment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05461820
Study Brief:
Protocol Section:
NCT05461820