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

Recruiting now · Phase 4

Conditions studied: Graves Disease, Relapse, Treatment, Drug Withdrawal

In brief

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.

Key facts

Study ID

NCT05461820

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

240

Starts

2018-05-01

Expected to finish

2030-07-31

Last updated by the study team

2023-12-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• the First Affiliated Hospital of Nanjing Medical University — Nanjing, China (enrolling)

Full record on ClinicalTrials.gov

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