Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease (NCT05461820) | Clinical Trial Compass
RecruitingPhase 4
Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
China240 participantsStarted 2018-05-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Cumulative recurrence rate between conventional treatment group and intensive treatment group after two years of withdrawal.
Timeframe: Up to 2 years after drug withdrawal
2
Number of patients with no adverse reactions during the treatment of Graves' disease
Timeframe: Within the treatment period (average 2 years)
Trial details
NCT IDNCT05461820
SponsorThe First Affiliated Hospital with Nanjing Medical University