Actively Recruiting
Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-12-11
240
Participants Needed
1
Research Sites
639 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Graves hyperthyroidism diagnosed by a doctor
- Age between 18 and 65 years, any gender
- Positive thyroid receptor antibody (TRAb) test
- Voluntary participation with signed informed consent
You will not qualify if you...
- Use of glucocorticoids or immunosuppressants for a long time within 3 months before selection
- Participation in any other drug trials within 3 months before selection
- Currently involved in clinical research of other drugs
- History of malignant tumors
- Poorly controlled high blood pressure (diastolic 60 100 mmHg or systolic 60 160 mmHg)
- Low white blood cell or neutrophil counts below specified limits
- Other thyroid diseases such as subacute thyroiditis, thyroid nodules, or high-function adenoma
- Elevated liver enzymes more than twice the normal limit or positive hepatitis B tests
- Kidney problems with high serum creatinine
- Heart failure or coronary heart disease
- Other autoimmune diseases
- Known allergy to methimazole or its components
- Multiple drug allergies or high sensitivity
- Alcoholism, mental disorders, or unsuitable for drug testing
- Pregnant or breastfeeding women or possible pregnancy
- Use of medicines with unknown ingredients or traditional Chinese medicine affecting treatment
- Other medical conditions or lifestyle factors that may complicate participation or follow-up
- Compliance outside 80%-120% during the trial
- Inability to cooperate or complete treatment and follow-up as planned
- Use of other drugs affecting the trial during the study
- Allergic or intolerant reactions to the study drug
- Development of other diseases interfering with treatment observation
- Pregnancy during the trial
- Investigator's judgment deeming inappropriate to continue participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
Research Team
X
Xuqin Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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