Myasthenia Gravis
Conditions
Interventions
TCM Treatment Group:Jianpi Bushen Decoction plus Western medicine
Control Group:Western medicine
Sponsors
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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 procedures, and their willingness to voluntarily participate in the study and comply with all study procedures. Subjects who initially sign the informed consent but subsequently withdraw it before receiving the study drug will be considered not to meet this inclusion criterion. 7. Must have the ability to read and write.
Exclusion criteria
Exclusion criteria: Concomitant Diseases or Past Medical History 1. History of severe and/or uncontrolled liver, gastrointestinal, kidney, lung, cardiovascular, psychiatric, neurological, or musculoskeletal diseases, hypertension, or any other medical condition that, in the investigator's opinion, may affect the patient's ability to complete the study, jeopardize the safety of the subject, or impact the efficacy of the study results. 2. History of MGFA Type I disease or myasthenic crisis (MGFA Type V) at screening, or history of myasthenic crisis within 1 month prior to screening. 3. Currently undergoing active radiation therapy or chemotherapy for unresected thymoma or malignant thymoma. Subjects with stable, benign thymomas (e.g., Stage I or IIa) who have not received treatment in the past 3 years may be allowed to participate after discussion with the medical monitor of the study team. 4. History of thymectomy within 12 months prior to screening or planned thymectomy during the study period. 5. Currently diagnosed with other malignancies not related to thymoma. 6. Positive for MuSK antibodies or LRP4 antibodies. 7. Currently breastfeeding or pregnant, planning to become pregnant during the study, or planning to donate eggs during the study or within 30 days after the last administration of the study drug. Acceptable Concomitant or Previous Treatments 8. Received rituximab treatment within 6 months prior to baseline. 9. Received plasmapheresis, immunoadsorption therapy, or intravenous immunoglobulin (IVIG) therapy within 6 weeks prior to baseline. Previous or Concurrent Clinical Trial Experience 10. Received investigational drugs (including investigational vaccines) within 3 months or 5 half-lives (whichever is longer) prior to the first planned administration of the study drug, or used invasive investigational medical devices within 3 months prior to the first planned administration of the study drug; or currently participating in another clinical study. Other Exclusion Criteria 11. Currently has suicidal ideation (i.e., answered "Yes" to Question 4 or 5 in the "Suicidal Ideation" section of the C-SSRS [specific scale details in Appendix 10] at screening or baseline) or history of active suicidal ideation or suicidal behavior within 1 year prior to screening. 12. Undergone major surgery (e.g., requiring general anesthesia) within 3 months prior to screening, has not fully recovered from surgery, or has planned surgery during the study period. 13. Situations where, in the investigator's opinion, participation in this study is not the best option (e.g., detrimental to health) or may affect, limit, or confound the assessment of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Myasthenia Gravis Daily Living Scale;Myasthenia Gravis Quantitative Scoring;Myasthenia Gravis Patient-Reported Outcome Measures Scale; | — |
Countries
China
Contacts
Public ContactLi Pei Wu
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital
Outcome results
None listed