myasthenia gravis
Conditions
Interventions
Treatment group:Buzhong Yiqi Pills+ Basic treatment regimen
Control group:placebo + basic treatment plan
Sponsors
Tangdu Hospital, Fourth Military Medical University of Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old and = 65 years old; 2. The subjects sign an informed consent form, are willing and able to comply with the protocol, complete the research evaluation, and return for follow-up; 3. MG diagnosis is defined as meeting any of the following criteria based on typical symptoms of fluctuating skeletal muscle weakness: a. Neostigmine test positive b. Abnormal neuromuscular transmission test results confirmed by single fiber Electromyography or repetitive nerve electrical stimulation (RNS) c. When screening, there is a confirmed positive result of AchR antibody (allowing repeated measurements); 4. The time from disease onset to screening is = 12 months; 5. At screening and baseline (V2 visit), MME (ADL = 1 point) or better status has been achieved and maintained for at least 4 weeks; 6. Cholinesterase inhibitor was received at baseline, and glucocorticoid could be used or not; 7. Male study participants must agree to take contraceptive measures during the treatment period and at least 90 days after the last dose of the study treatment, and sperm donation is prohibited throughout the entire study period; 8. If you are a woman with Fertility (WOCBP), you must agree to take contraceptive measures during the treatment period and at least 90 days after the last administration of the study drug. At the time of screening, the participants' serum Pregnancy test results must be negative; Before the first administration of the baseline study drug, the urine Pregnancy test results must be confirmed as negative.
Exclusion criteria
Exclusion criteria: If any of the following criteria are met during screening and baseline, study participants are not eligible for this study: 1. Any medical or mental condition that the researcher believes may endanger the study participants or affect their ability to participate in this study; 2. Have a history of drug or alcohol abuse within the 12 months prior to screening, or any condition that the investigator believes is related to poor compliance; 3. Women who are breastfeeding or pregnant, or those who plan to become pregnant at any time during the period from signing the Informed Consent Form (ICF) until 6 months after the last medication, or those who have a history of natural or induced abortion within the first 4 weeks of screening; 4. The initiator, on-site staff, and their family members; 5. Non hormonal Immunosuppressive drug other than hormones were used at baseline; 6. Thymoma that received thymectomy or planned thymectomy during RCP within 6 months before baseline, or that requires chemotherapy and/or radiotherapy at any time; 7. Study participants received Rituximab treatment in the first 6 months before baseline; 8. Known patients with serious basic diseases, such as liver and kidney function damage, blood disease, serious cardiovascular disease, severe hypertension, diabetes, and poor control of blood pressure and glucose; 9. Unresected Thymoma (Note: Subjects who have resected benign Thymoma more than one year before screening can be selected. Benign is defined as having no known metastasis in pathological examination and not extending in or out of the capsule. Imaging examination must be performed before randomization to assess the thymus status). 10. During the screening period, any of the following laboratory abnormalities occurred (during the screening period, a repeated measurement can be conducted before randomization to confirm the results) a. Liver enzymes increased (Aspartic acid Transaminase (AST) or alanine Transaminase (ALT)>2.5 times the upper normal limit (ULN)). b. Total bilirubin>1.5 times ULN c. Estimated glomerular filtration rate (eGFR)<45 mL/min/1.73 m2 d. CD19+B cell count<40 cells/µ L e. Absolute neutrophil count (ANC)<1.2 × one hundred and nine f. Platelet count<75000/ µ L (or<75 × 109/L) g. Hemoglobin<8.0g/dL h. Total immunoglobulin<600 mg/dL 11. During the screening period, hepatitis B surface antigen (HBsAg) was positive; 12. During the screening period, the results of hepatitis C antibody or RNA testing were positive; 13. The HIV (HIV) test result is positive during the screening period 14. Have a clear history of allergies to traditional Chinese medicine ingredients such as Astragalus membranaceus, licorice, Codonopsis pilosula, Atractylodes macrocephala, Angelica sinensis, Cimicifuga, Bupleurum chinense, and tangerine peel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease relapse occurred during the study period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average weighted steroids dose;Hospitalization days due to myasthenia worsening;Intubation or mechanical ventilation due to myasthenia worsening; | — |
Countries
China
Contacts
Public ContactChang Ting
Tangdu Hospital, Fourth Military Medical University of Chinese People's Liberation Army
Outcome results
None listed