Effectiveness of Modified Buzhong Yiqi Decoction in treating myasthenia gravis: study protocol for a series of N-of-1 trial

Not Applicable

Recruiting

• Conditions: myasthenia gravis

• Registration Number: ITMCTR2000004105
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
QMG score;

Secondary Outcome Measures

Name	Time	Method
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;