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Recruiting Phase 4 NCT05461820

Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease

Trial Parameters

Condition Graves Disease
Sponsor The First Affiliated Hospital with Nanjing Medical University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2018-05-01
Completion 2023-12-31
Interventions
Methimazole

Brief Summary

In this study, the dose of methimazole was adjusted according to the different states of thyroid function, and the effects of conventional therapy and intensive therapy on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal were evaluated. At the same time, the changes of immune indexes and inflammatory factors in the regulation process were evaluated. This study is a phase IV clinical study designed and carried out by the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), which is a randomized, open and routine treatment group with parallel control.

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 lim

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