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

StatusRecruiting
PhasePhase 4
Started2018-05-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 11, 2023 (before its estimated December 31, 2023 completion). Its status may not reflect the trial's current state.

Amendment history

2023-12-08
minor
Study Status v2
Primary completion date2023-07-31→2023-12-31
2022-07-21
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing v1
Eligibility criteria+56 characters
[...] diastolic blood pressure≥100mmHg, systolic blood pressure ≥160mmHg160 mmHg Blood routine: the total number of white blood cells < 3.0× [...] ubacute 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 [...]
Secondary endpointsdetails revised at 1 of 4 entries
Primary endpoints2 entries, revised
Number of patients with no adverse reactions during the teatmenttreatment of Graves' disease
2022-07-13
minor
Original filing
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.
Trial Details
NCT Number NCT05461820
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Graves Disease, Relapse, Treatment, Drug Withdrawal
Enrollment 240 participants
Start Date 2018-05-01
Primary Completion 2023-12-31 (estimated)
Study Completion 2030-07-31 (estimated)
Updated on ClinicalTrials.gov 2023-12-11