To evaluate the efficacy and safety of Bailing capsule combined with methimazole versus methimazole monotherapy in the treatment of Graves' disease: a randomized controlled clinical trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Treatment group:Bailing capsule combined with methimazole;control group:Methimazole; CONDITION: Graves' Disease PRIMARY OUTCOME: Difference of TRAb titer from baseline; SECONDARY OUTCOME: Difference of TRAb titer from baseline;The negative conversion rate of TRAb in patients;The first time of TRAb negative conversion;Difference of thyroid peroxidase antibody (TPOAb) titer from baseline;Difference of thyroid hormones (FT3, FT4, TSH) from baseline;Proportion of patients whose thyroid hormones returned to normal;The first normal time of thyroid hormone;Difference of thyroid volume from baseline;Difference of ThyPRO‐39 score in the quality of life of patients from baseline;The dose of methimazole used;Difference of cytokines (TNF‐a, IFN‐?, IL‐2, IL‐4, IL‐6, IL‐10) from baseline.; INCLUSION CRITERIA: Patients who meet all of the following screening criteria would be eligible (1) Patients with Graves' disease, newly diagnosed patients or relapsed patients after drug withdrawal for more than one year; (2) TSH receptor antibody (TRAb) positive (> 1.75 IU/L); (3) Age of 18‐65 years old (including 18 years old and 65 years old), regardless of gender; (4) Voluntarily participated in this clinical trial, informed consent and signed informed consent.
Epistemonikos ID: d9b9a3935a3f545f2d30512076b2618136f63e4b
First added on: Feb 20, 2024