Study on the Efficacy of Spleen-Strengthening and Kidney-Tonifying Formula in Treating Generalized Severe Myasthenia Gravis

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: TCM Treatment Group:Jianpi Bushen Decoction plus Western medicine;Control Group:Western medicine; CONDITION: Myasthenia Gravis PRIMARY OUTCOME: Hormone dose‐time effect weighted average;Expression levels of AChR‐Ab, CXCL13, and BAFF in human blood samples.;Traditional Chinese Medicine (TCM) Syndrome Efficacy; SECONDARY OUTCOME: Myasthenia Gravis Daily Living Scale;Myasthenia Gravis Quantitative Scoring;Myasthenia Gravis Patient‐Reported Outcome Measures Scale; INCLUSION CRITERIA: 1. Be =18 years of age at the time of signing the informed consent. Subject Type and Disease Characteristics 2. Diagnosed with myasthenia gravis (MG), with generalized muscle weakness at screeningMGFA clinical classification IIa/b, IIIa/b, or IVa/b categories, and positive acetylcholine receptor antibody (AChR‐Ab). 3. Daily oral prednisone acetate tablets dose =10mg or equivalent dose of other glucocorticoids. 4. Chinese syndrome differentiation diagnosis of spleen‐kidney deficiency (refer to the standard "Guidelines for Internal Medicine Diagnosis and Treatment in Traditional Chinese Medicine ‐ Myasthenia Gravis" by the Chinese Association of Traditional Chinese Medicine, 2019 edition). 5. Negative pregnancy test for women of childbearing potential and no intention to become pregnant during the study. Informed Consent Form 6. Subjects must sign the ICF, indicating their understanding of the purpose of the study and the required procedur
Epistemonikos ID: 8963b6545b971941caede31114cedd1480033089
First added on: Jan 24, 2026