Prospective, randomized, controlled, double-blind clinical study of traditional Chinese medicine combined with glucocorticoid in the treatment of generalized myasthenia gravis

Not Applicable

• Conditions: Myasthenia Gravis

• Registration Number: ITMCTR2100005054
• Lead Sponsor: Zhejiang Provincial Hospital of Traditional 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The first onset meets the diagnostic criteria for generalized myasthenia gravis;
2. Complete admission data, detailed condition description, complete disease course record and no obvious missing items;
3. Application of glucocorticoid therapy;
4. Aged over 18 years old;
5. The diagnosis of GMG was re-verified by at least two attending physicians or higher-level physicians based on typical clinical phenotypes and laboratory test results.

Exclusion Criteria

1. Patients with other neuromuscular diseases or peripheral neuropathy;
2. Combined with serious cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases, chronic severe infection, mental illness;
3. Pregnant or lactating women;
4. Those who use other immunosuppressants;
5. The application of traditional Chinese medicine including traditional Chinese medicine or acupuncture has been started before enrollment;
6. Those who have been enrolled in other clinical intervention studies and have conflicts with the observation of this topic;
7. Those who meet any of the above items will be excluded.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Myasthenia gravis quantitative score (qMGS),;myasthenia gravis absolute and relative score (ARS-MG);myasthenia gravis muscle scale (MMS);the relapse rate after hormone reduction,The incidence rate of hormone complications,and conversion rate of Myasthenia gravis crisis;myasthenia gravis complex scale (MGC);

Secondary Outcome Measures

Name	Time	Method
MG daily life scale (MG-ADL);