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 range
18 Years – 65 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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