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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how different treatment plans impact the management and recurrence of Graves' disease, which is a condition that causes the thyroid gland to become overactive. Specifically, researchers are looking at how adjusting the dose of a medication called methimazole affects the chances of Graves' hyperthyroidism coming back after stopping the medication for two years. The study also aims to understand the changes in the immune system during this treatment process.

To be eligible for the study, participants should be between 18 and 65 years old and have a confirmed diagnosis of Graves' hyperthyroidism with a specific positive antibody test. Those who have recently taken certain medications, have other serious health issues, or are pregnant or breastfeeding are not eligible. Participants can expect regular monitoring and follow-ups throughout the study. This research is important because it could help improve treatment strategies for Graves' disease and potentially reduce the chances of it returning after stopping medication.

Gender

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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.