myasthenia gravis
Conditions
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged between 18 to 65 years; 2) Patients diagnosed with MG based on The Chinese guidelines for the diagnosis and treatment of myasthenia gravis (2020): patients with typical clinical features of MG (fluctuating myasthenia) excluded from other diseases and meeting any of the following three points, including pharmacological examination, electrophysiological characteristics or serum antibody detection; 3) Patients attached to the spleen-stomach deficiency syndrome or spleen-kidney deficiency syndrome will be enrolled which is based on The guidelines for clinical diagnosis and treatment of internal medicine of traditional Chinese Medicine: myasthenia gravis (2020); 4) Patients identified as class II or III according to myasthenia gravis foundation of America (MGFA) clinical classification and are in the stable stage of MG at least 3 months; 5) Patients with Quantitative Myasthenia Gravis (QMG) score more than 6; 6) Patients treated with glucocorticoid administration should not take more than 15mg prednisone (or an equivalent dose of other glucocorticoids) per day.
Exclusion criteria
Exclusion criteria: 1) Female patients who are pregnant or lactating or have a pregnancy plan during the trial; 2) Patients with other autoimmune diseases (e.g., polymyositis, multiple sclerosis, rheumatoid arthritis) that may impact the assessment and treatment; 3) Patients with severe heart, kidney, liver, lung, hematological system, infectious diseases or cancer; 4) Patients with neuropsychiatric disorders that cannot cooperate; 5) Patients received plasma exchange, glucocorticoid or gamma-globin pulse therapy within 3 months; 6) Patients received thymectomy within half a year; 8) Patients participating in other trials; 9) Patients consumed antibiotics, probiotics or anti-acids during the previous two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QMG score; | — |
Secondary
| Measure | Time frame |
|---|---|
| MGC;MGQOL;level of Treg cells and cytokines (IL-4, IL-17A, INF-?, TGF-ß);the composition of gut microbiota;MG-pro;MG-ADL;reduction of the side effects; | — |
Countries
China
Contacts
Public ContactFengbin Liu
Department of spleen and stomach, First Affiliated Hospital of Guangzhou University of TCM
Outcome results
None listed